{"id":137,"date":"2021-04-27T06:18:57","date_gmt":"2021-04-27T13:18:57","guid":{"rendered":"https:\/\/catrials.org\/?page_id=137"},"modified":"2024-04-23T13:14:41","modified_gmt":"2024-04-23T20:14:41","slug":"research","status":"publish","type":"page","link":"https:\/\/catrials.org\/research\/","title":{"rendered":"Research"},"content":{"rendered":"

[et_pb_section fb_built=”1″ inner_shadow=”on” fullwidth=”on” _builder_version=”4.16″ background_color=”#2ea3f2″ use_background_color_gradient=”on” background_color_gradient_direction=”330deg” background_color_gradient_stops=”#2ea3f2 0%|#2e6df4 100%” background_color_gradient_start=”#2ea3f2″ background_color_gradient_end=”#2e6df4″ global_colors_info=”{}”][et_pb_fullwidth_header title=”Clinical Research Trials” content_max_width=”none” admin_label=”Clinical Research Trials” module_id=”researchtop” _builder_version=”4.16″ global_colors_info=”{}” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”4px|||||” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”65px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_slider admin_label=”What is clinical research? Slider” _builder_version=”4.16″ _module_preset=”default” background_color=”RGBA(0,0,0,0)” custom_margin=”5px|-71px|0px|-71px|false|false” custom_margin_tablet=”0px|-50px|0px|-50px|false|false” custom_margin_phone=”|-25px||-25px|false|false” custom_margin_last_edited=”on|desktop” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_slide heading=”WHAT IS CLINICAL RESEARCH?” _builder_version=”4.16″ _module_preset=”default” header_level=”h3″ header_font=”|700||on|||||” header_text_align=”left” header_text_color=”#000000″ header_font_size=”20px” body_text_align=”justify” body_text_color=”#000000″ background_color=”RGBA(0,0,0,0)” background_enable_color=”on” text_orientation=”justified” background_layout=”light” custom_padding=”0px|0px|0px|0px|false|false” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” header_font_size_tablet=”” header_font_size_phone=”16px” header_font_size_last_edited=”on|desktop” body_text_align_tablet=”” body_text_align_phone=”left” body_text_align_last_edited=”on|tablet” global_colors_info=”{}” sticky_transition=”on”]<\/p>\n

Clinical research is developed when medical professionals try to expand knowledge of a particular medical condition, treatment, or question.\u00a0 Human volunteers (also called participants or subjects) are required to help answer these important questions and improve medical knowledge.<\/p>\n

Observational studies<\/strong>\u00a0gather information about participants with a specific condition or diagnosis in order to learn more about their condition, without requiring specific interventions or treatments.\u00a0 An example of an observational study is a registry where participants’ health records are reviewed every year.<\/p>\n

Clinical trials\u00a0<\/strong>also involve participants with a specific condition or diagnosis, but an intervention or set of interventions are tested to try to improve patient care.\u00a0 Sometimes different medications, procedures, or medical devices are tested and compared to see if one treatment is better than others or has different side effects than current treatments.\u00a0 An example of a clinical trial is a study of two different medications being used to treat a condition.<\/p>\n

All clinical research conducted at VCAT is reviewed by a Clinical Research Ethics Board (CREB) and must be approved before it can proceed.\u00a0 CREBs are made of a group of people who oversee studies and their participants, and ensure that research complies with federally-mandated regulations (such as those from Health Canada or the US Food and Drug Administration).\u00a0 The CREB for Vancouver Island is the Island Health Clinical Research Ethics Board<\/span><\/strong><\/span><\/a>.<\/p>\n

[\/et_pb_slide][\/et_pb_slider][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”on|off|off” _builder_version=”4.16″ _module_preset=”default” width=”90%” module_alignment=”center” custom_margin=”|5px||5px|false|true” custom_padding=”1px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”COVID-19 PANDEMIC” open_toggle_text_color=”#5a0c1c” open_toggle_background_color=”#dbd9d9″ closed_toggle_text_color=”#5a0c1c” closed_toggle_background_color=”#dbd9d9″ disabled_on=”on|off|off” admin_label=”COVID-19 Toggle Computer\/Tablet” _builder_version=”4.16″ _module_preset=”default” title_text_color=”#000000″ title_level=”h2″ title_font=”|800|||||||” title_font_size=”20px” closed_title_font=”|800||on|||||” closed_title_text_align=”left” closed_title_font_size=”20px” body_text_align=”justify” body_text_color=”#000000″ width=”100%” max_width=”90%” module_alignment=”center” custom_margin=”||||false|false” custom_margin_tablet=”|148px||-28px|false|false” custom_margin_phone=”|-50px||-50px|false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” animation_style=”slide” border_width_all=”5px” border_color_all=”#5a0c1c” border_style_all=”groove” global_colors_info=”{}”]<\/p>\n

Please be aware that VCAT is complying with all local requirements for research during the COVID-19 pandemic, including the use of medical grade masks for all staff and patients.\u00a0 As guidance from Island Health and the Province of BC changes, so too will VCAT’s policies regarding research during the pandemic.\u00a0 All VCAT team members are vaccinated against COVID-19, as per Island Health requirements<\/span><\/a><\/strong>.<\/p>\n

If you are currently participating in a research study with VCAT, or are considering participation, please be aware that there may be COVID-related risks associated with research visits.\u00a0 VCAT tries to mitigate these risks by adhering to local guidelines, but you should be aware of these potential risks.\u00a0 Island Health has developed notices to inform study participants of these risks.\u00a0 We invite you to read and review these notices before you decide to participate in any research project at this time.<\/p>\n

Island Health Notice for participants in registries\/observational trials<\/strong><\/a><\/span>
(where no specific intervention is required by the study, but your progress or status is observed by the research team over a period of time)<\/p>\n

Island Health Notice for participants in interventional trials<\/strong><\/a><\/span>
(where a specific intervention, such as administration of a certain drug or therapy is required by the study)<\/p>\n

[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|on|on” _builder_version=”4.16″ _module_preset=”default” width=”100%” module_alignment=”center” custom_margin=”|150px||50px|false|false” custom_padding=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”COVID-19 PANDEMIC” open_toggle_text_color=”#5a0c1c” open_toggle_background_color=”#dbd9d9″ closed_toggle_text_color=”#5a0c1c” closed_toggle_background_color=”#dbd9d9″ disabled_on=”off|on|on” admin_label=”COVID-19 Toggle Phone” _builder_version=”4.16″ _module_preset=”default” title_text_color=”#000000″ title_level=”h2″ title_font=”|800|||||||” title_font_size=”20px” closed_title_font=”|800||on|||||” closed_title_text_align=”left” closed_title_font_size=”20px” body_text_align=”left” body_text_color=”#000000″ text_orientation=”left” module_alignment=”center” overflow-x=”visible” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”|10px||10px|false|true” custom_margin_last_edited=”on|desktop” custom_padding=”||||false|false” animation_style=”slide” border_width_all=”5px” border_color_all=”#5a0c1c” border_style_all=”groove” global_colors_info=”{}”]<\/p>\n

Please be aware that VCAT is complying with all local requirements for research during the COVID-19 pandemic, including the use of medical grade masks for all staff and patients.\u00a0 As guidance from Island Health and the Province of BC changes, so too will VCAT’s policies regarding research during the pandemic.\u00a0 All VCAT team members are vaccinated against COVID-19, as per Island Health requirements<\/span><\/a><\/strong>.<\/p>\n

If you are currently participating in a research study with VCAT, or are considering participation, please be aware that there may be COVID-related risks associated with research visits.\u00a0 VCAT tries to mitigate these risks by adhering to local guidelines, but you should be aware of these potential risks.\u00a0 Island Health has developed notices to inform study participants of these risks.\u00a0 We invite you to read and review these notices before you decide to participate in any research project at this time.<\/p>\n

Island Health Notice for participants in registries\/observational trials<\/strong><\/a><\/span>
(where no specific intervention is required by the study, but your progress or status is observed by the research team over a period of time)<\/p>\n

Island Health Notice for participants in interventional trials<\/strong><\/a><\/span>
(where a specific intervention, such as administration of a certain drug or therapy is required by the study)<\/p>\n

[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”-23px|auto||auto||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Some of the terms listed may be unfamiliar to you. Please contact our office for more information.” _builder_version=”4.16″ _module_preset=”default” text_text_color=”#474747″ text_font_size=”11px” global_colors_info=”{}”]<\/p>\n

Some of the terms listed may be unfamiliar to you. Please contact our office for more information.<\/em><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”on|off|off” admin_label=”Row Computer\/Tablet” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”Current Research” open=”on” open_toggle_text_color=”#000000″ closed_toggle_text_color=”#000000″ icon_color=”#0400f0″ use_icon_font_size=”on” icon_font_size=”20px” open_icon_color=”#0400f0″ open_use_icon_font_size=”on” open_icon_font_size=”20px” disabled_on=”on|off|off” admin_label=”Current Research” _builder_version=”4.21.0″ _module_preset=”default” title_text_color=”#000000″ title_font=”|700|||||||” closed_title_font=”|700|||||||” body_text_color=”#000000″ module_alignment=”left” custom_padding=”||||false|false” hover_enabled=”0″ body_text_align_tablet=”” body_text_align_phone=”left” body_text_align_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”11px” body_font_size_last_edited=”on|desktop” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Project Name<\/strong><\/td>\nSummary<\/strong><\/td>\nFor More Information…<\/strong><\/td>\n<\/tr>\n
APPRAISE ATP<\/strong><\/td>\n\n

Patients with a Boston Scientific implantable cardioverter defibrillator (ICD) with decreased cardiac function are eligible to be randomized to 2 different ICD settings.<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT02923726<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ARTESiA<\/strong><\/td>\n\n

Patients with an implanted cardiac device (pacemaker, ICD, loop recorder) with device-detected atrial arrhythmias are eligible to be randomized to 2 different medications for stroke prevention: Aspirin versus Apixaban (Eliquis).<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT01938248<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ATLAS S-ICD<\/strong><\/td>\n\n

Patients requiring a single chamber ICD are eligible to be randomized to 2 different types of ICD: transvenous versus subcutaneous.<\/p>\n

Enrollment and follow-up of study participants concluded in January 2022; results are currently pending.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT02881255<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

AWARE<\/strong><\/td>\n\n

Patients with a history of episodic (paroxysmal) atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.<\/p>\n

Enrollment and follow-up of study participants concluded in October 2021; study results are pending.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT02150902<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

CAPLA<\/strong><\/td>\n\n

Patients with a history of persistent atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n<\/td>\n

\n

ANZCTR.org.au<\/p>\n

Identifier: ACTRN12616001436460<\/a><\/strong><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

CATCH-AF<\/strong><\/td>\nPatients with a history of episodic symptoms that may be due to arrhythmia (for example: palpitations, shortness of breath, or pre-syncope) are eligible to be randomized to 2 different methods of heart rhythm monitoring: standard rhythm monitoring (Holter monitor) versus smart device monitoring (Kardia\/AliveCor).<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT04302311<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

COAST-AF<\/strong><\/td>\nPatients with a history of persistent atrial fibrillation (episode over 3 months in duration) who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT03347227<\/strong><\/a><\/span><\/p>\n<\/td>\n<\/tr>\n

DREAM-SICD
<\/strong><\/td>\n		\n

Retrospective chart review of patients receiving a subcutaneous ICD (S-ICD) at eight Canadian centres between January 1, 2016, and May 1, 2020. The purpose of this chart review is to evaluate the rate of appropriate and inappropriate device therapies after implant of an S-ICD, in order to provide supporting data for determining appropriate driving restrictions after S-ICD device implant.<\/p>\n

Chart review has concluded for this study; publication is currently pending.<\/em><\/p>\n<\/td>\n

Canadian Journal of Cardiology Publication<\/span><\/strong><\/a><\/td>\n<\/tr>\n
EARLY-AF<\/strong><\/td>\n\n

Patients with a history of atrial fibrillation are eligible to be randomized to 2 different treatment options to prevent further arrhythmias: medication with antiarrhythmic drugs versus ablation treatment.<\/p>\n

Enrollment and follow-up of study participants concluded in March 2022; overall study results are pending.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT02825979<\/a><\/strong><\/span><\/p>\n

Interim Results: New England Journal of Medicine<\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

HiRO Registry<\/strong><\/td>\nPatients with inheritable heart rhythm conditions (such as Brugada Syndrome, Long QT syndrome, unexplained cardiac arrest, and arrhythmogenic right ventricular cardiomyopathy – ARVC) and their close relatives are followed in this registry.\u00a0 Participants are eligible to complete Biobanking.\u00a0 This registry includes patients formerly enrolled in CASPER<\/em>,\u00a0LQT<\/em>, and\u00a0ARVC<\/em>.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT04189822<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

HiRO-HCM<\/strong><\/td>\nPatients with hypertrophic cardiomyopathy (HCM) or with a gene variant associated with HCM are eligible to participate in this registry and associated biobank. The purpose of this registry is to address current knowledge gaps in this condition.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT05100420<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

LEFT HF<\/strong><\/td>\nSelect patients undergoing dual chamber pacemaker implant are eligible to be randomized to receive 2 different types of lead placement: standard lead placement (right ventricular pacing) or a different lead placement (left bundle branch pacing). This is a vanguard (feasibility) study.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT05015660<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

LIBREXIA-AF<\/strong><\/td>\nPatients with a history of atrial fibrillation or atrial flutter are randomized to an experimental anticoagulant, milvexian, or to apixaban. The study will determine if milvexian yields a comparable benefit in the context of a reduced risk of bleeding.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT05757869<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

NODE-301 – RAPID<\/strong><\/td>\nPatients with a history of episodic supraventricular tachycardia (SVT) are eligible to participate in this study of etripamil nasal spray.\u00a0 Participants undergo safety evaluations using etripamil under supervision, and are then randomized to receive either etripamil or placebo to treat episodes of SVT.\u00a0 This is a Phase 3 safety and efficacy study of an Investigational Product (etripamil).<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT03464019<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

NODE-303<\/strong><\/td>\nPatients with a history of episodic supraventricular tachycardia (SVT) are eligible to participate in this study of etripamil nasal spray.\u00a0 Participants undergo screening procedures, and are then provided with etripamil to treat episodes of SVT.\u00a0 This is a Phase 3 safety study of an Investigational Product (etripamil).<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT04072835<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

NODE-X<\/strong><\/td>\nPatients with a history of episodic supraventricular tachycardia (SVT) and who have previously participated in either NODE 301, NODE 302, or NODE 303 are eligible to participate in this extension study of etripamil nasal spray. \u00a0This is a Phase 3 open label extension study of an Investigational Product (etripamil).<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT04952610<\/a><\/span><\/strong><\/p>\n

Health Canada Identifier: Control<\/strong> Number 247598<\/strong><\/a><\/span><\/p>\n<\/td>\n<\/tr>\n

OCEAN<\/strong><\/td>\n\n

Patients with a history cardiac risk factors and successful ablation for atrial fibrillation are eligible to be randomized to 2 different medications for long-term stroke prevention: Aspirin versus Rivaroxaban (Xarelto).<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT02168829<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

POST 7<\/strong><\/td>\nPatients with a history of vasovagal syncope and at least 2 faints in the past year are enrolled and randomized to receive either atomoxetine or placebo for the prevention of future syncopal events.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT05159687<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

RAFT-AF<\/strong><\/td>\n\n

Patients with both atrial fibrillation and symptomatic heart failure (NYHA Class 2-3) are eligible to be randomized to either rhythm control (pulmonary vein ablation) or rate control (with medications or AV node ablation) for treatment of atrial fibrillation.<\/p>\n

Enrollment and follow-up of study participants concluded in January 2020.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT01420393<\/strong><\/span><\/a><\/p>\n

American College of Cardiology<\/span><\/a><\/strong><\/p>\n

Circulation Results<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

RAFT AF EXTEND<\/strong><\/td>\nPatients who participated in the RAFT-AF study are assessed approximately 30 months following their final RAFT-AF study visit. The purpose of the study is to determine whether there is a long-term benefit to patients who received an atrial fibrillation ablation versus rate control during their RAFT-AF participation.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT05118893<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

RAFT-PermAF<\/strong><\/td>\nPatients with a history of atrial fibrillation and heart failure who are candidates for ICD implantation are eligible to be randomized to receive 2 different types of devices: single chamber ICD versus cardiac resynchronization therapy ICD (CRT-D).<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT01994252<\/a><\/strong><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

REFINE-ICD<\/strong><\/td>\nPatients with a history of heart attack and mildly decreased cardiac function are screened to assess for additional risk factors for future heart rhythm problems.\u00a0 Participants who are found to have these risk factors are eligible to be randomized to risk reduction with medication versus insertion of an ICD.\u00a0 Participants without these risk factors are followed in a registry.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT00673842<\/a><\/strong><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

RPM-CIED: ICD<\/strong><\/td>\nPatients with an implanted Medtronic or Abbott Implantable Cardioverter-Defibrillator (ICD) are randomized to management of their device either exclusively through remote monitoring versus the current standard of care (in-clinic visits).\u00a0 Patients in the remote monitoring arm use the VIRTUES platform, developed by CANet, to view information about their device reports.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT03405740<\/strong><\/a><\/span><\/p>\n

C<\/span><\/strong>ANet information<\/strong><\/span><\/a><\/p>\n

VIRTUES information<\/span><\/strong><\/a><\/p>\n<\/td>\n<\/tr>\n

RPM-CIED: PPM<\/strong><\/td>\nPatients with an implanted Medtronic or Abbott pacemaker are randomized to management of their device either exclusively through remote monitoring versus the current standard of care (in-clinic visits). Patients in the remote monitoring arm use the VIRTUES platform, developed by CANet to view information about their device reports.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT03636230<\/strong><\/a><\/span><\/p>\n

C<\/strong>ANet information<\/strong><\/a><\/p>\n

VIRTUES information<\/strong><\/a><\/p>\n<\/td>\n<\/tr>\n

STAR-AF 3<\/strong><\/td>\nPatients with a history of symptomatic persistent atrial fibrillation (episodes between 3 months and 3 years in duration) who are undergoing ablation are eligible to be randomized to 3 different methods of ablation.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT04428944<\/strong><\/a><\/span><\/p>\n<\/td>\n<\/tr>\n

SyncAV<\/strong><\/td>\nPatients with a history of decreased cardiac output who are candidates for cardiac resynchronization therapy devices (CRT-pacemaker or CRT-D) are eligible to be randomized to 2 different device programming methods.<\/td>\n\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT04100148<\/a><\/strong><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

VANISH 2<\/strong><\/td>\n\n

Patients with a history of heart attack and ventricular tachycardia who either have or will be receiving an ICD are eligible to be randomized to 2 different treatment arms for prevention of future arrhythmias: medication with antiarrhythmic drugs versus ablation treatment.<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n<\/td>\n

\n

ClinicalTrials.gov<\/p>\n

Identifier: NCT02830360<\/a><\/strong><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Return to top<\/strong><\/span><\/a><\/p>\n

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[\/et_pb_toggle][et_pb_toggle title=”Completed Research” open_toggle_text_color=”#000000″ closed_toggle_text_color=”#000000″ icon_color=”#0400f0″ use_icon_font_size=”on” icon_font_size=”20px” open_icon_color=”#0400f0″ open_use_icon_font_size=”on” open_icon_font_size=”20px” disabled_on=”on|off|off” admin_label=”Completed Research” _builder_version=”4.16″ _module_preset=”default” title_text_color=”#000000″ title_font=”|700|||||||” closed_title_font=”|700|||||||” body_text_color=”#000000″ text_orientation=”justified” global_colors_info=”{}”]<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Project Name<\/strong><\/td>\nSponsor<\/strong><\/td>\nSummary<\/strong><\/td>\nYear Project Closed<\/strong><\/td>\nFor More Information…<\/strong><\/td>\n<\/tr>\n
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction<\/strong><\/td>\nWyeth Research (now an owned subsidiary of Pfizer)<\/td>\n\n

The purpose of this study was to learn the effects of a test drug (GAP-486) on heart rhythms which may become life-threatening if left untreated (Ventricular Tachyarrhythmia), and to provide data to see if the drug was well tolerated and safe.<\/p>\n

Results:<\/strong><\/span> The study was terminated early due to lack of drug efficacy.<\/p>\n<\/td>\n

2006<\/td>\nClinicalTrials.gov Identifier: NCT00137332<\/strong><\/span><\/a><\/td>\n<\/tr>\n
ABLATOR<\/strong><\/td>\nSt Jude Medical International, Inc (now Abbott Medical Devices)<\/td>\n\n

The purpose of this registry was to assess the performance and clinical effectiveness of a combination of St Jude Medical mapping and ablation products in the treatment of patients with atrial fibrillation (AF).\u00a0 All participants were already planned to undergo an ablation procedure for AF and consented to participate in this observational registry.\u00a0 The primary outcome of the study was freedom from AF and other atrial arrhythmias with or without the use of anti-arrhythmic drugs after the 3-month blanking period post-ablation.<\/p>\n

Results:<\/strong><\/span> 2035 patients signed consent, and 1932 patients received ablation therapy and completed 12 months of follow-up in the study.\u00a0 Of these 1932 participants, 1297 remained free from atrial arrhythmias at 12 months post-ablation.<\/p>\n<\/td>\n

2018<\/td>\nClinicalTrials.gov Identifier: NCT02344173<\/strong><\/span><\/a><\/td>\n<\/tr>\n
ACT I<\/strong><\/td>\nCardiome Pharma Corp (now Advanz Pharma)<\/td>\n\n

This study was conducted to demonstrate the effectiveness of investigational drug RSD1235 (vernakalant) in the conversion of atrial fibrillation to sinus rhythm.<\/p>\n

Results:<\/strong><\/span> Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.<\/p>\n<\/td>\n

2004<\/td>\nClinicalTrials.gov Identifier: NCT00468767<\/a><\/strong><\/span>
<\/a>PubMed.gov Identifier: 18332267<\/a><\/strong><\/span><\/td>\n<\/tr>\n
ACT V<\/strong><\/td>\nAstellas Pharma Canada (now Advanz Pharma)<\/td>\n\n

The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.<\/p>\n

A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045) (ACT V).<\/p>\n

Results:<\/strong> <\/span>Vernakalant resulted in rapid cardioversion of recent-onset AF in almost half of the study population and was generally well tolerated. The safety outcomes affirmed the need for careful selection and management of haemodynamically stable candidates for cardioversion.<\/p>\n<\/td>\n

2010<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00989001<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 27233239<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ACTIVE A<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack, or left ventricular dysfunction etc.<\/p>\n

Results:<\/strong><\/span> In patients with atrial fibrillation for whom vitamin K-antagonist therapy was unsuitable, the addition of clopidogrel to aspirin reduced the risk of major vascular events, especially stroke, and increased the risk of major hemorrhage.<\/p>\n<\/td>\n

2009<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00249873<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 19336502<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ACTIVE I<\/strong><\/td>\nSanofi<\/td>\n\n

\u00a0The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.<\/p>\n

Results:<\/strong><\/span> Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation.<\/p>\n<\/td>\n

2009<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00249795<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 21388310<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ADAPTIVE CRT (aCRT)<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study is to demonstrate the Medtronic AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance.<\/p>\n

Results:<\/strong><\/span> Higher percent synchronized Left Ventricular Pacing (sLVP)\u00a0 was independently associated with superior clinical outcomes. In patients with normal AV conduction, the aCRT algorithm provided mostly sLVP and demonstrated better clinical outcomes compared to the control (echocardiography-optimized Bi-Ventricular Pacing, BVP).<\/p>\n<\/td>\n

2012<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00980057<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 23851059<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ADONIS<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation\/atrial flutter (AF\/AFL), to assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF\/AFL recurrence, and to assess the efficacy of dronedarone versus placebo on AF\/AFL-related symptoms.<\/p>\n

Results:<\/strong><\/span> Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.<\/p>\n<\/td>\n

2003<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00259376<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 17804843<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ADVICE<\/strong><\/td>\nMontreal Heart Institute<\/td>\n\n

The primary objective of the ADVICE trial was to evaluate the impact of adenosine-guided Pulmonary Vein Isolation (PVI) in preventing Atrial Fibrillation (AF) recurrences among patients with paroxysmal AF. We hypothesize that a PVI ablation strategy that incorporates elimination of dormant conduction unmasked by intravenous adenosine will decrease symptomatic AF recurrence compared to standard PVI, without incurring significant additional risk.<\/p>\n

Results:<\/strong><\/span> Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation. This approach should be considered for incorporation into routine clinical practice.<\/p>\n<\/td>\n

2013<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01058980<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 26211828<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

AF-CHF<\/strong><\/td>\nMontreal Heart Institute<\/td>\n\n

Congestive heart failure (CHF) and atrial fibrillation (AF) are two important and growing problems in medicine and cardiology. Both conditions often co-exist and complicate each other’s management. Two therapeutic strategies are available for patients with AF and CHF: the first aims at restoring and maintaining sinus rhythm, whereas, the second focuses exclusively on optimizing ventricular rate. The primary objective of the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is to compare these two widely-used treatment strategies with respect to cardiovascular mortality.<\/p>\n

Results:<\/strong><\/span> In patients with atrial fibrillation and congestive heart failure, a routine strategy of rhythm control does not reduce the rate of death from cardiovascular causes, as compared with a rate-control strategy.<\/p>\n<\/td>\n

2007<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00597077<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 18565859<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ALPHEE<\/strong><\/td>\nSanofi<\/td>\n\n

The Primary objective was to assess the efficacy and safety of a new antiarrhythmic agent, Celivarone, for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.<\/p>\n

Results:<\/strong><\/span> Celivarone was not effective for the prevention of ICD interventions or sudden death.<\/p>\n<\/td>\n

2011<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00993382<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 22082672<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

AMADEUS<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 (idraparinux), compared withvitamin K antagonist tablets (warfarin or acenocoumarol tablets) in patients with atrial fibrillation and risk for clots.<\/p>\n

Results:<\/strong><\/span> In patients with atrial fibrillation at risk for thromboembolism, long-term treatment with idraparinux was no worse than vitamin K antagonists in terms of efficacy, but caused significantly more bleeding.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00070655<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 18294998<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

Amiodarone Aqueous I.V. Injection – Protocol # 0585K1-312-CA<\/strong><\/td>\nWyeth-Ayerst Research and Wyeth-Ayerst Canada Inc.<\/td>\n\n

The purpose of this study was to collect safety information about 2 forms of the drug intravenous (I.V.) amiodarone.\u00a0 One form of amiodarone (Cordarone I.V.) was approved for marketing in 1995 for treatment of ventricular fibrillation and ventricular tachycardia.\u00a0 The other form of amiodarone (Amiodarone Aqueous I.V.) is currently being investigated.<\/p>\n

Results:<\/strong><\/span> Wyeth-Ayerst decided to terminate this study after an interim analysis has indicated that the investigational aqueous formulation was associated with a higher incidence of phlebitis (inflammation of a vein) as compared with Cordarone IV.<\/p>\n<\/td>\n

2002<\/td>\nWyeth-Ayerst<\/a><\/strong><\/span><\/td>\n<\/tr>\n
ARISTOTLE<\/strong><\/td>\nBristol-Myers Squibb<\/td>\n\n

The purpose of this trial was to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.<\/p>\n

Results:<\/strong><\/span> In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.<\/p>\n<\/td>\n

2011<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00412984<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 21870978<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ASPECT AT500<\/strong><\/td>\nMedtronic<\/td>\n\n

The objective of this study will be to use specific atrial lead placement to investigate the efficacy of the atrial arrhythmia prevention pacing features.\u00a0 Lead placement sites will include septal and non-septal atrial pacing sites.<\/p>\n

Results:<\/strong><\/span> The combination of three atrial prevention pacing algorithms did not decrease device classified atrial tachyarrhythmia frequency or burden during a 3-month cross-over period in bradycardic patients and septal or nonseptal atrial pacing leads. Prevention pacing was associated with decreased frequency of premature atrial contractions and with decreased symptomatic atrial tachyarrhythmia frequency in patients with atrial septal leads.<\/p>\n<\/td>\n

2003<\/td>\nPubMed.gov Identifier 14678133<\/a><\/strong><\/span><\/td>\n<\/tr>\n
ASSERT<\/strong><\/td>\nSt Jude Medical (now Abbott Medical Devices)<\/td>\n\n

The purpose of the study was to determine whether the detection of AHRE (atrial high rate episodes) with pacemaker telemetry predicts an increased risk of stroke in elderly hypertensive patients without prior AF and to determine whether the AF Suppression Algorithm reduces the risk of development of symptomatic AF in elderly hypertensive patients without prior AF receiving a pacemaker for sinus or AV node disease.<\/p>\n

Results:<\/strong><\/span> Subclinical atrial tachyarrhythmias, without clinical atrial fibrillation, occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism.<\/p>\n<\/td>\n

2012<\/td>\nNew England Journal of Medicine article<\/a><\/strong><\/span><\/td>\n<\/tr>\n
ASSERT-II<\/strong><\/td>\nPopulation Health Research Institute<\/td>\n\n

The primary objective of the study was to determine the rate of detection of sub-clinical atrial fibrillation (\u2265 5 minutes)within an average of 12 months following implant of the St. Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF.<\/p>\n

Results:<\/strong><\/span> SCAF is frequently detected by continuous electrocardiographic monitoring in older patients without a history of atrial fibrillation who are attending outpatient cardiology and neurology clinics. Its clinical significance is unclear.<\/p>\n<\/td>\n

2016<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01694394<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 28778946<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ATHENA<\/strong><\/td>\nSanofi<\/td>\n\n

A placebo-controlled, double-blind, parallel arm trial to assess the efficacy of Dronedarone 400mg po BID to prevent cardiovascular hospitalization or death from any cause in patients with atrial fibrillation\/ atrial flutter.<\/p>\n

Results:<\/strong><\/span> Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.<\/p>\n<\/td>\n

2008<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00174785<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 19213680<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

BRUISE CONTROL<\/strong><\/td>\nOttawa Heart Institute Research Corporation<\/td>\n\n

The purpose of this study was to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery.<\/p>\n

Results:<\/strong><\/span> As compared with bridging therapy with heparin, a strategy of continued warfarin treatment at the time of pacemaker or ICD surgery markedly reduced the incidence of clinically significant device-pocket hematoma.<\/p>\n<\/td>\n

2013<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00800137<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 23659733<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

BRUISE CONTROL 2<\/strong><\/td>\nOttawa Heart Institute Research Corporation<\/td>\n\n

The purpose of this study was to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesized that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.<\/p>\n

Results:<\/strong><\/span> These results suggest that, dependent on the clinical scenario, either management strategy (continued DOAC or interrupted DOAC) might be reasonable, at least for patients similar to those enrolled in our trial.<\/p>\n<\/td>\n

2018<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01675076<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 30462279<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

CART-HF<\/strong><\/td>\nGuidant, Inc. (now part of Boston Scientific Corporation)<\/td>\n\n

This study analyzed resource utilization and related costs associated with CHF for patients who receive standard implantable cardiac defibrillators (ICDs) versus those who receive ICD plus biventricular pacing or cardiac resynchronization therapy (CRT).<\/p>\n

Results:<\/strong><\/span> These analyses indicate that savings in post-implant health-care utilization (hospitalizations and pharmacological therapy) can offset some of the device and procedural costs associated with CRT devices.<\/p>\n<\/td>\n

2007<\/td>\nPubMed.gov Identifier: 17241313<\/a><\/strong><\/span><\/td>\n<\/tr>\n
CIRCA-DOSE<\/strong><\/td>\nUniversity of British Columbia<\/td>\n\n

Patients with paroxysmal AF were randomized to either radiofrequency ablation, cryoablation 2 min, or cryoablation 4 min for reduction in recurrent arrhythmias.<\/p>\n

Results:<\/strong><\/span> In this multicenter, randomized, single-blinded trial, radiofrequency ablation and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring.<\/p>\n<\/td>\n

2019<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01913522<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 31630538<\/a><\/strong><\/span><\/p>\n

Heart Rhythm Journal article<\/strong><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

CO1<\/strong><\/td>\nBiosense Webster, Inc.<\/td>\n\n

The purpose of this study was to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO\u00ae 3 or the NavX(TM) System.<\/p>\n

Results:<\/strong><\/span> This study was terminated early due to enrollment challenges.<\/p>\n<\/td>\n

2010<\/td>\nClinicalTrials.gov Identifier: NCT01036724<\/a><\/strong><\/span><\/td>\n<\/tr>\n
CONTAK CD and TR: Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure<\/strong><\/td>\nGuidant, Inc. (now part of Boston Scientific Corporation)<\/td>\n\n

The purpose of this study was to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular pacing with defibrillation.<\/p>\n

Results:<\/strong><\/span> In patients with advanced heart failure and a prolonged QRS interval, cardiac-resynchronization therapy decreases the combined risk of death from any cause or first hospitalization and, when combined with an implantable defibrillator, significantly reduces mortality.<\/p>\n<\/td>\n

2002<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00180258<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 15152059<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

CORONA: Models 4074\/4574<\/strong>
Transvenous Steroid Eluting Pacing Leads Study<\/strong><\/td>\n		Medtronic Inc.<\/td>\n\n

This study assessed the safety and performance of the ventricular Model 4074 and atrial Model 4574 pacing leads. All patients had a clinical indication for a dual chamber pacemaker implant.<\/p>\n

Results:<\/strong><\/span> Model 4074 ventricular lead and Model 4574 atrial lead were approved for use.<\/p>\n<\/td>\n

2001<\/td>\n\n

Medtronic Lead 4074<\/strong><\/span><\/a><\/p>\n

Medtronic Lead 4574<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

CORYFEE<\/strong><\/td>\nSanofi<\/td>\n\n

This was a double-blind study to assess versus placebo the efficacy of investigational antiarrhythmic drug SSR149744C (celivarone) for the conversion of atrial fibrillation\/flutter to sinus rhythm at the time of a planned electrical cardioversion.<\/p>\n

Results:<\/strong><\/span> In this study, celivarone did not appear to be efficacious in the maintenance of sinus rhythm in AF\/AFL patients or for the conversion of AF\/AFL patients.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00232310<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 22171925<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

CREDIT<\/strong><\/td>\nGuidant, Inc. (now part of Boston Scientific Corporation)<\/td>\n\n

Canadian Registry of ICD Implant Testing Procedures.\u00a0 The purpose of this registry was to document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.<\/p>\n

Results:<\/strong><\/span> Defibrillation testing was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.<\/p>\n<\/td>\n

2008<\/td>\nClinicalTrials.gov Identifier: NCT00848341<\/a><\/strong><\/span>
<\/a>
Journal of Cardiovascular Electrophysiology article<\/a><\/strong><\/span><\/td>\n<\/tr>\n
CREDO<\/strong><\/td>\nAbbott Canada<\/td>\n\n

Canadian Registry of Cardiac Implantable Electronic Device Outcomes.\u00a0 This prospective observational study included patients with an Abbott device subject to the advisory, from 9 centres in Canada. The incidence and outcomes related to device revision owing to premature battery depletion were identified and adjudicated by a committee.<\/p>\n

Results:<\/strong><\/span> The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low.\u00a0 With the current practice of active surveillance, vibratory alert and remote monitoring, and a novel battery monitoring system, no clinical adverse events associated with PBD were found.\u00a0 This study reaffirms the Abbott reports on the incidence of this advisory and did not find any evidence of adverse clinical events, supporting the current Canadian Heart Rhythm Society recommendations of enhanced monitoring, without the need for early device replacement.<\/p>\n<\/td>\n

2019<\/td>\nCJC Open article<\/a><\/strong><\/span><\/td>\n<\/tr>\n
CTAF-2<\/strong><\/td>\nMontreal Heart Institute<\/td>\n\n

The purpose of this study was to determine the efficacy of 8 mg\/day oral perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential hypertension.<\/p>\n

Results:<\/strong><\/span> Perindopril does not reduce recurrence or the number of AF episodes in patients with hypertension and AF.<\/p>\n<\/td>\n

2015<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00461903<\/a><\/strong><\/span><\/p>\n

CJC Open article<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

DEFEAT-HF<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure (HF).<\/p>\n

Results:<\/strong><\/span> The present study does not provide evidence to support a meaningful change in clinical outcomes for HF patients receiving SCS.<\/p>\n<\/td>\n

2015<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01112579<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 26682789<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

DINAMIT<\/strong><\/td>\nSt Jude Medical (now Abbott Medical Devices)<\/td>\n\n

The purpose of this research study was to test whether or not the automatic implantable defibrillator (ICD) helps patients who have had a recent heart attack (myocardial infarction) live longer by preventing cardiac arrest.<\/p>\n

Results:<\/strong><\/span> Prophylactic ICD therapy does not reduce overall mortality in high-risk patients who have recently had a myocardial infarction. Although ICD therapy was associated with a reduction in the rate of death due to arrhythmia, that was offset by an increase in the rate of death from non-arrhythmic causes.<\/p>\n<\/td>\n

2004<\/td>\n\n

New England Journal of Medicine article<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 15590950<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

DISCERN AF<\/strong><\/td>\nOttawa Heart Institute Research Corporation<\/td>\n\n

The purpose of this study was to assess the amount of Atrial Fibrillation (AF) that occurs before and after an ablation procedure associated with symptoms versus AF that is not associated with any symptoms.\u00a0 This study sought to confirm whether patients’ symptoms or lack of symptoms post-ablation correlate well with actual episodes of AF.<\/p>\n

Results:<\/strong><\/span> The ratio of asymptomatic to symptomatic AF episodes increased from 1.1 before to 3.7 after ablation.\u00a0 Post-ablation state is the strongest predictor of asymptomatic AF.\u00a0 Symptoms alone underestimate post-ablation AF burden, with 12% of patients having asymptomatic recurrences only.<\/p>\n<\/td>\n

2014<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00745706<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 23266597<\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

DUO-FLAIR<\/strong><\/td>\nSt Jude Medical Inc (now Abbott Medical Devices)<\/td>\n\n

The purpose of the study was to demonstrate the safety and efficacy of the use of the new St Jude Therapy Cool Path Duo\u2122 cardiac ablation system for the treatment of typical atrial flutter (cavotricuspid isthmus dependent).<\/p>\n

Results:<\/strong><\/span> Cool Path Duo\u2122 irrigated tip catheter is safe and effective in treating typical atrial flutter.\u00a0 When compared to a six-hole irrigated tip catheter, the Cool Path Duo catheter delivers more power at a lower temperature.<\/p>\n<\/td>\n

2013<\/td>\nJournal of Interventional Cardiac Electrophysiology article<\/a><\/strong><\/span><\/td>\n<\/tr>\n
ELECTION<\/strong><\/td>\nGuidant Corporation (now part of Boston Scientific Corporation)<\/td>\n\n

This study served to evaluate the benefits of having various pace\/sense electrode configurations available in a cardiac resynchronization therapy (CRT) system from Guidant.<\/p>\n

Results:<\/strong><\/span> Electronic repositioning is an important tool in the management of CRT patients which may help to lower thresholds, avoid phrenic nerve stimulation, and prevent unnecessary re-operations for lead repositioning.<\/p>\n<\/td>\n

2008<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00848653<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 21273196<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

ELECTRA<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to determine whether the administration of dronedarone (400 mg twice a day) started 5 to 7 days before and after planned cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of new atrial fibrillation (AF) episodes.<\/p>\n

Results:<\/strong><\/span> There is no difference in the AF recurrence rates and other variables between the patients starting dronedarone before cardioversion or after cardioversion.<\/p>\n<\/td>\n

2011<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01026090<\/a><\/strong><\/span><\/p>\n

Sanofi<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

EMPIRIC<\/strong><\/td>\nMedtronic Inc.<\/td>\n\n

This trial sought to the hypothesis that the shock-related morbidity of implantable cardioverter defibrillator (ICD) therapy is similar whether patients are treated with a standardized empiric programming regimen for ventricular tachycardia\/ventricular fibrillation (VT\/VF) detection and therapy vs. with a patient-specific, physician-tailored approach.<\/p>\n

Results:<\/strong><\/span> Standardized empiric ICD programming for VT\/VF settings is at least as effective as patient-specific, physician-tailored programming, as measured by many clinical outcomes.\u00a0 Simplified and pre-specified ICD programming is possible without an increase in shock-related morbidity.<\/p>\n<\/td>\n

2004<\/td>\n\n

Journal of the American College of Cardiology article<\/a><\/strong><\/span><\/p>\n

FDA News article<\/a><\/strong><\/span><\/p>\n

Current Controlled Trials in Cardiovascular Medicine article<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

EnRhythm MRI<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this clinical study was to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI\u2122 SureScan\u2122 Pacing System by Medtronic (used in support of Revo MRI\u2122 SureScan Pacing System launch).<\/p>\n

Results:<\/strong><\/span> This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.<\/p>\n<\/td>\n

2010<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00433654<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 19055703<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

FLEXION-AFL<\/strong><\/td>\nSt Jude Medical Inc (now Abbott Medical Devices)<\/td>\n\n

The purpose of this trial was to demonstrate that ablation with the St Jude Therapy\u2122 Cool Flex\u2122 Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.<\/p>\n

Results:<\/strong><\/span> The FLEXION AFL pivotal study demonstrated that the Therapy Cool Flex Ablation Catheter met the safety goal and the efficacy performance goal for its intended use as defined in the clinical protocol.\u00a0 As a result, this system was approved for use by the FDA.<\/p>\n<\/td>\n

2012<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01408485<\/a><\/strong><\/span><\/p>\n

FDA Approval information<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

Fortify\u2122\/Unify\u2122 New Technology Assessment (NTA)<\/strong><\/td>\nSt Jude Medical International, Inc (now Abbott Medical Devices)<\/td>\n\n

The primary purpose of this study was to evaluate the overall device function and performance of the new Fortify\u2122 implantable cardioverter defibrillator (ICD) and Unity\u2122 ICD with cardiac resynchronization therapy (CRT-D) made by St. Jude Medical, not yet approved by Health Canada.<\/p>\n

Results:<\/strong><\/span> These devices are now approved for use.<\/p>\n<\/td>\n

2010<\/td>\nBiospace article<\/strong><\/span><\/a><\/td>\n<\/tr>\n
GEM III<\/strong><\/td>\nMedtronic Inc.<\/td>\n\n

The purpose of this clinical study was to evaluate the safety and effectiveness of the investigational GEM III DR implantable cardioverter defibrillator (ICD), Model 7275, system by Medtronic, used to control heart rhythm problems.<\/p>\n

Results:<\/strong><\/span> The GEM III DR ICD was approved for use.<\/p>\n<\/td>\n

2000<\/td>\nMed Device Online article<\/a><\/strong><\/span><\/td>\n<\/tr>\n
GLORIA-AF Registry<\/strong><\/td>\nBoehringer Ingelheim<\/td>\n\n

In these second and third phases of the GLORIA-AF registry program, patients with non-valvular atrial fibrillation (AF) at risk for stroke were enrolled to characterize the target population and to collect real world data on important outcome events.\u00a0 Anticoagulation use was observed and compared.<\/p>\n

Results:<\/strong><\/span> GLORIA-AF findings reinforce a favourable benefit-risk profile for anticoagulation with dabigatran (Pradaxa) compared with Vitamin K antagonists (warfarin) in routine clinical practice among patients with newly diagnosed AF.<\/p>\n<\/td>\n

2020<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01468701<\/a><\/strong><\/span><\/p>\n

Boehringer Ingelheim<\/strong><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

ICI COOL PATH<\/strong><\/td>\nIrvine Biomedical, Inc. (a St Jude Medical company)<\/td>\n\n

The purpose of this study was to compare the safety and effectiveness of an investigational ablation catheter (the IBI Therapy Cool Path Ablation Catheter) with approved ablation catheters for the treatment of typical atrial flutter.\u00a0 An investigational device is one that has not been approved by the Food and Drug Administration (FDA) in the United States or the Health Products and Food Branch (HPFB) in Canada.<\/p>\n

Results:<\/strong><\/span> The IBI Therapy Cool Path Ablation Catheter was approved for use for treatment of Atrial Flutter in 2007.<\/p>\n<\/td>\n

2007<\/td>\nFDA Report P060019<\/a><\/strong><\/span><\/td>\n<\/tr>\n
ICY AVNRT<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to determine if the Medtronic Freezor\u00ae Xtra Surgical Cardiac CryoAblation catheter (“cryoablation catheter\u201d) is safe and effective for the treatment of a kind of cardiac arrhythmia (atrioventricular nodal reentrant tachycardia – AVNRT).<\/p>\n

Results:<\/strong><\/span> Cryoablation for AVNRT using a focal 6-mm catheter was safe and effective. It resulted in a low risk of recurrence over 6 months of follow-up with no incidence of AV block requiring permanent pacing.<\/p>\n<\/td>\n

2016<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01426425<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 29044787<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

LEAD LIFE<\/strong><\/td>\nGuidant Corporation (now part of Boston Scientific Corporation)<\/td>\n\n

The purpose of the LEAD LIFE study was to collect information regarding the performance of the ENDOTAK ENDURANCE EZ and ENDOTAK RELIANCE family of transvenous defibrillation leads. This was a prospective, non-randomized, multi-centre, observational clinical study.<\/p>\n

Results:<\/strong><\/span> The LEAD LIFE study demonstrated that the leads were safe and reliable over time.\u00a0 Characterization of implant location, lead selection, and defibrillation testing were consistent across all sites.\u00a0 There were minimal complications and observations in the study.<\/p>\n<\/td>\n

2004<\/td>\nClinicalTrials.gov Identifier: NCT00848835<\/a><\/strong><\/span><\/td>\n<\/tr>\n
LEARN<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

This was a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design was an observational examination of LV thresholds over time.\u00a0 The Medtronic Concerto CRT-ICD device was used in this study.<\/p>\n

Results:<\/strong><\/span> This study demonstrated that the Left Ventricular Capture Management (LVCM) algorithm is safe, accurate, and highly reliable. LVCM worked with different types of leads and different lead locations. LVCM was demonstrated to be clinically equivalent to the manual LV threshold test. LVCM offers automatic measurement, output adaptation, and trends of the LV threshold and should result in improved ability to maintain LV capture without sacrificing device longevity.<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01089634<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 17897121<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

Long term outcomes following pacemaker implantation and atrioventricular node ablation for management of atrial fibrillation
<\/strong><\/td>\n		VCAT – Academic<\/td>\n\n

The purpose of this retrospective chart review was to determine long-term safety and effectiveness of pacemaker implant plus AV node ablation (“pace and ablate” strategy) for management of atrial fibrillation, and to compare outcomes between patients who undergo both pacemaker implant and AV node ablation on the same day versus on two different days. This study included patients from the Royal Jubilee Hospital in BC and the Sunshine Coast University Hospital in Australia.<\/p>\n

Results:<\/strong><\/span> Pacemaker implant and AV node ablation may be performed safely together in a single procedure (i.e. same day) and can potentially lead to improved patient convenience and cost savings.<\/p>\n<\/td>\n

2018<\/td>\nHeart Lung and Circulation<\/a><\/strong><\/span><\/td>\n<\/tr>\n
MAIA<\/strong><\/td>\nSanofi<\/td>\n\n

In this study, patients with atrial fibrillation or atrial flutter were randomized to receive one of amiodarone, investigational anti-arrhythmic drug celivarone (at one of 4 different doses), or placebo when in normal sinus rhythm.\u00a0 The purpose of this study was to evaluate the efficacy and tolerability of <\/span>celivarone and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological, or spontaneous conversion of atrial fibrillation or atrial flutter.<\/span><\/p>\n

Results:<\/strong><\/span> In this study, celivarone did not appear to be efficacious in the maintenance of sinus rhythm in atrial fibrillation or atrial flutter<\/span> patients or for the conversion of atrial fibrillation or atrial flutter<\/span> patients.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00233441<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 22171925<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

MATRIX<\/strong><\/td>\nBiotronik SE & Co. KG<\/td>\n\n

In this registry, patients with no history of atrial fibrillation and who were scheduled to receive a single chamber ICD were implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX (or successor single chamber DX system) to assess if this ICD system effectively and accurately detected atrial fibrillation.<\/p>\n

Results:<\/strong><\/span> Pending<\/em><\/strong><\/p>\n<\/td>\n

2020<\/td>\nClinicalTrials.gov Identifier: NCT01774357<\/a><\/strong><\/span><\/td>\n<\/tr>\n
MODEL 4195 Left Ventricular Lead<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also “steroid-eluting” which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.<\/p>\n

Results:<\/strong><\/span> This lead was approved for release to US markets in 2008.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00269230<\/a><\/strong><\/span><\/p>\n

Medtronic Lead 4195 Attain StarFix<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

MODEL 6949<\/strong><\/td>\nMedtronic, Inc.<\/td>\n\n

The purpose of this registry was to assess the handling and performance of the new Model 6949 lead from Medtronic, Inc (Sprint Fidelis).\u00a0 This lead was used in connection with an ICD system used to control a dangerously fast-beating heart.\u00a0 The Model 6949 lead was investigational at this time, which means it was not yet approved by the Therapeutic Products Directorate (TPD) of Health Canada and was not available to the general public.<\/p>\n

Results:<\/strong><\/span> The Model 6469 Sprint Fidelis lead was approved for use.\u00a0 Since this time, there has been an advisory on this lead, though it was not recommended to prophylactically replace the lead.<\/p>\n<\/td>\n

2004<\/td>\n\n

Medtronic Lead 6949 Sprint Fidelis<\/a><\/strong><\/span><\/p>\n

Government of Canada Recall Notice<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

MVP TRIAL<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to determine whether atrial pacing with ventricular backup pacing is equivalent to ventricular backup pacing only in implantable cardioverter-defibrillator (ICD) patients.\u00a0 This study compared these two programming options for their effects on how much electrical pulse therapy patients received from the ICD and how frequently they are hospitalized for their heart condition. There were no experimental procedures in this trial.<\/p>\n

Results:<\/strong><\/span> This study was terminated due to an inability to reach statistical significance towards the primary endpoint (reduction in all cause mortality and heart failure hospitalizations or urgent care visits).\u00a0 Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated.<\/p>\n<\/td>\n

2009<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00281099<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 20685401<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

NODE 302<\/strong><\/td>\nMilestone Pharmaceuticals Inc<\/td>\n\n

The NODE-302 study was an open-label safety extension of the NODE-301 efficacy study. It was a multi-centre, open label study designed to evaluate the safety of etripamil NS 70 mg when self-administered by patients for spontaneous episodes of PSVT in an outpatient setting, and to provide supporting data for the NODE 301 study.<\/p>\n

Results:<\/strong><\/span> This study was completed in late 2020 in order to focus on NODE 301.\u00a0 As approval of etripamil depends on the results from NODE 301, results from NODE 302 will contribute to the etripamil NDA safety database.<\/p>\n<\/td>\n

2020<\/td>\nClinicalTrials.gov Identifier: NCT03635996<\/a><\/strong><\/span><\/td>\n<\/tr>\n
OPTIC<\/strong><\/td>\nSt Jude Medical (now Abbott Medical Devices)<\/td>\n\n

This study was an open parallel design randomized trial of 3 different medication regimes for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation.\u00a0 The 3 medication regimes were: 1- amiodarone plus a beta blocker, 2- a beta blocker alone, and 3- sotalol.\u00a0 The objective was to determine whether amiodarone plus a beta blocker or sotalol were superior to beta blocker alone.<\/p>\n

Results:<\/strong><\/span> Amiodarone plus beta-blocker is effective for preventing these shocks and is more effective than sotalol but has an increased risk of drug-related adverse effects.<\/p>\n<\/td>\n

2004<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00257959<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 16403928<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

PainFree SST<\/strong><\/td>\nMedtronic, Inc.<\/td>\n\n

Phase 2 of the Safety and Clinical Performance of the Protect ICD and CRT-D study (Phase I: PROTECTA).\u00a0\u00a0 The purpose of the PainFree SmartShock Technology (SST) study was to evaluate the impact of the new SST features in reducing inappropriate ICD shocks.\u00a0 Patients were randomized to either standard detection duration or prolonged detection duration by their ICD; the study question was whether providing more time for rhythm analysis prior to delivery of a shock would allow the ICD to correctly identify and treat the patient’s heart rhythm with greater success.<\/p>\n

Results:<\/strong><\/span> In a large patient cohort receiving ICDs for primary or secondary prevention, the adoption of novel enhanced detection algorithms in conjunction with routine implementation of modern programming strategies led to a very low inappropriate shock rate.<\/p>\n<\/td>\n

2014<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00982397<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 25637563<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 26988379<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

PALLAS<\/strong><\/td>\nSanofi-Aventis<\/td>\n\n

Patients with a history of atrial fibrillation episodes 6 months or longer and risk factors for major cardiovascular events (such as stroke, heart attack, or cardiovascular death) were randomized to receive an antiarrhythmic drug called dronedarone (also known as Multaq) versus placebo.\u00a0 The objective was to demonstrate the efficacy of dronedarone in preventing these major cardiovascular events, unplanned cardiovascular hospitalizations, or all cause mortality in this patient population.<\/p>\n

Results:<\/strong><\/span> This study was stopped for safety purposes.\u00a0 Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in this patient population.\u00a0 Dronedarone should not be used in these patients.<\/p>\n<\/td>\n

2012<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01151137<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 22082198<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

POST 4<\/strong><\/td>\nUniversity of Calgary<\/td>\n\n

Patients with a history of vasovagal syncope (fainting) were randomized to receive either an investigational medication called Midodrine or a placebo to prevent future episodes of syncope.<\/p>\n

Results:<\/strong><\/span> Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden.<\/p>\n<\/td>\n

2020<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01456481<\/a><\/strong><\/span><\/p>\n

Annals of Internal Medicine article<\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

RE-CIRCUIT<\/strong><\/td>\nBoehringer Ingelheim<\/td>\n\n

Patients with a history of atrial fibrillation undergoing pulmonary vein ablation were randomized to receive either uninterrupted warfarin or uninterrupted dabigatran etexilate (Pradaxa) for prevention of stroke in this exploratory study.\u00a0 The primary objective was to assess safety of uninterrupted dabigatran compared to warfarin during the time of the ablation, with secondary objectives being to assess safety endpoints (such as major and minor bleeds, strokes, TIAs, and other embolic events) and efficacy.\u00a0 Patients received either dabigatran 150 mg twice daily or warfarin as needed to maintain an INR between 2.0 and 3.0.<\/p>\n

Results:<\/strong><\/span> In patients undergoing ablation for atrial fibrillation, anticoagulation with uninterrupted dabigatran was associated with fewer bleeding complications than uninterrupted warfarin.<\/p>\n<\/td>\n

2017<\/td>\n\n

ClinicalTrials.gov Identifier: NCT02348723<\/a><\/strong><\/span><\/p>\n

PubMed.gov Identifier: 28317415<\/strong><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

Scene 2Cardiome Pharma Corp (now Advanz Pharma)<\/strong><\/td>\n\u00a0<\/td>\n\n

This study attempted to demonstrate the effectiveness of investigational drug RSD1235 (vernakalant) in the conversion of atrial flutter (AFL) to sinus rhythm.<\/p>\n

Results:<\/strong><\/span> Vernakalant did not restore sinus rhythm in patients with AFL. Vernakalant modestly slowed AFL and ventricular response rates, and was well tolerated.<\/p>\n<\/td>\n

2004<\/td>\n\n

ClinicalTrials.gov Identifier: NCT00476112<\/strong><\/span><\/a><\/p>\n

PubMed.gov Identifier: 22291438<\/strong><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

SHIELD-2<\/strong><\/td>\nForest Laboratories<\/td>\n\n

This study was done to evaluate the efficacy and safety of an investigational antiarrhythmic drug, Azimilide, on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits, or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs).<\/p>\n

Results:<\/strong><\/span> This study was terminated early due to Sponsor funding withdrawal.\u00a0 The SHIELD-2 trial was statistically underpowered due to early trial termination and did not meet its primary objective.\u00a0 Despite this limitation, azimilide, a class III antiarrhythmic drug, showed promise in this study as a safe and effective drug for potentially reducing the number of shocks, unplanned hospitalizations, and ED visits in ICD patients. These data support prior clinical trial findings with this drug including the SHIELD study.<\/p>\n<\/td>\n

2013<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01464476<\/strong><\/span><\/a><\/p>\n

American Heart Journal article<\/strong><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

SPRITELY<\/strong><\/td>\nUniversity of Calgary<\/td>\n\n

Patients with a history of syncope (fainting) and bifascicular heart block (conduction abnormality in the electrical system of the heart where electrical signals are slowed down) were randomized to receive either a pacemaker or an implantable ECG loop recorder.\u00a0 The primary outcome was a composite of syncope\/pre-syncope associated with a slow heart rate (bradycardia), stable complete heart block, or device-related complication.<\/p>\n

Results:<\/strong><\/span> Pacing with a pacemaker (compared to observation only with an implantable loop recorder) reduced major adverse outcomes but did not reduce syncope in older patients with bifascicular block and syncope.\u00a0 There remains a substantial chance of recurrent syncope in patients who receive a pacemaker, as this syncope is likely due to other causes (such as vasodepressor syncope).<\/p>\n<\/td>\n

2017<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01423994<\/strong><\/span><\/a><\/p>\n

PubMed.gov Identifier: 35210082<\/strong><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n

X-VERT<\/strong><\/td>\nBayer<\/td>\n\n

This study randomized patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm) to receive either Rivaroxaban or vitamin K antagonist (VKA) for stroke prevention at the time of their cardioversion. The study measured common medical outcomes for this type of patient such as bleeding and stroke.<\/p>\n

Results:<\/strong><\/span> Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.<\/p>\n<\/td>\n

2014<\/td>\n\n

ClinicalTrials.gov Identifier: NCT01674647<\/strong><\/span><\/a><\/p>\n

PubMed.gov Identifier: 25182247<\/a><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\u00a0<\/strong><\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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APPRAISE ATP<\/strong><\/h3>\n

Patients with a Boston Scientific implantable cardioverter defibrillator (ICD) with decreased cardiac function are eligible to be randomized to 2 different ICD settings.<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n

ClinicalTrials.gov\u00a0Identifier:\u00a0NCT02923726<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

ARTESiA<\/strong><\/h3>\n

Patients with an implanted cardiac device (pacemaker, ICD, loop recorder) with device-detected atrial arrhythmias are eligible to be randomized to 2 different medications for stroke prevention: Aspirin versus Apixaban (Eliquis).<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n

ClinicalTrials.gov\u00a0Identifier:\u00a0NCT01938248<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

ATLAS S-ICD<\/strong><\/h3>\n

Patients requiring a single chamber ICD are eligible to be randomized to 2 different types of ICD: transvenous versus subcutaneous.<\/p>\n

Enrollment and follow-up of study participants concluded in January 2022; results are currently pending.<\/em><\/p>\n

ClinicalTrials.gov\u00a0Identifier:\u00a0NCT02881255<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

AWARE<\/strong><\/h3>\n

Patients with a history of episodic (paroxysmal) atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.<\/p>\n

Enrollment and follow-up of study participants concluded in October 2021; study results are pending.<\/em><\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT02150902<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

CAPLA<\/strong><\/h3>\n

Patients with a history of persistent atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n

ANZCTR.org.au\u00a0<\/span>Identifier:\u00a0ACTRN12616001436460<\/a><\/strong><\/span><\/span><\/p>\n

 <\/p>\n

CATCH-AF<\/strong><\/h3>\n

Patients with a history of episodic symptoms that may be due to arrhythmia (for example: palpitations, shortness of breath, or pre-syncope) are eligible to be randomized to 2 different methods of heart rhythm monitoring: standard rhythm monitoring (Holter monitor) versus smart device monitoring (Kardia\/AliveCor).<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT04302311<\/a><\/strong><\/span><\/p>\n

\u00a0<\/h3>\n

COAST-AF<\/strong><\/h3>\n

Patients with a history of persistent atrial fibrillation (episode over 3 months in duration) who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.<\/p>\n

ClinicalTrials.gov Identifier: NCT03347227<\/strong><\/span><\/a><\/p>\n

 <\/p>\n

DREAM-SICD<\/strong><\/h3>\n

Retrospective chart review of patients receiving a subcutaneous ICD (S-ICD) at eight Canadian centres between January 1, 2016, and May 1, 2020. The purpose of this chart review is to evaluate the rate of appropriate and inappropriate device therapies after implant of an S-ICD, in order to provide supporting data for determining appropriate driving restrictions after S-ICD device implant.<\/p>\n

Chart review has concluded for this study; publication is currently pending.<\/em><\/p>\n

Canadian Journal of Cardiology Publication<\/span><\/strong><\/a><\/p>\n

 <\/p>\n

EARLY-AF<\/strong><\/h3>\n

Patients with a history of atrial fibrillation are eligible to be randomized to 2 different treatment options to prevent further arrhythmias: medication with antiarrhythmic drugs versus ablation treatment.<\/p>\n

Enrollment and follow-up of study participants concluded in March 2022; overall study results are pending.<\/em><\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT02825979<\/a><\/strong><\/span><\/p>\n

Interim Results:\u00a0New England Journal of Medicine<\/a><\/span><\/strong><\/p>\n

 <\/p>\n

HiRO Registry<\/strong><\/h3>\n

Patients with inheritable heart rhythm conditions (such as Brugada Syndrome, Long QT syndrome, unexplained cardiac arrest, and arrhythmogenic right ventricular cardiomyopathy – ARVC) and their close relatives are followed in this registry.\u00a0 Participants are eligible to complete Biobanking.\u00a0 This registry includes patients formerly enrolled in\u00a0CASPER<\/em>,\u00a0LQT<\/em>, and\u00a0ARVC<\/em>.<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT04189822<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

HiRO-HCM<\/strong><\/h3>\n

Patients with hypertrophic cardiomyopathy (HCM) or with a gene variant associated with HCM are eligible to participate in this registry and associated biobank. The purpose of this registry is to address current knowledge gaps in this condition.<\/p>\n

ClinicalTrials.gov Identifier:\u00a0NCT05100420<\/strong><\/a><\/span><\/p>\n

LEFT HF<\/strong><\/h3>\n

Select patients undergoing dual chamber pacemaker implant are eligible to be randomized to receive 2 different types of lead placement: standard lead placement (right ventricular pacing) or a different lead placement (left bundle branch pacing). This is a vanguard (feasibility) study.<\/p>\n

ClinicalTrials.gov Identifier:\u00a0NCT05015660<\/a><\/strong><\/span><\/p>\n

LIBREXIA-AF<\/strong><\/h3>\n

Patients with a history of atrial fibrillation or atrial flutter are randomized to an experimental anticoagulant, milvexian, or to apixaban. The study will determine if milvexian yields a comparable benefit in the context of a reduced risk of bleeding.<\/p>\n

ClinicalTrials.gov Identifier:\u00a0NCT05757869<\/a><\/strong><\/span><\/p>\n

NODE-301 – RAPID<\/strong><\/h3>\n

Patients with a history of episodic supraventricular tachycardia (SVT) are eligible to participate in this study of etripamil nasal spray.\u00a0 Participants undergo safety evaluations using etripamil under supervision, and are then randomized to receive either etripamil or placebo to treat episodes of SVT.\u00a0 This is a Phase 3 safety and efficacy study of an Investigational Product (etripamil).<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT03464019<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

NODE-303<\/strong><\/h3>\n

Patients with a history of episodic supraventricular tachycardia (SVT) are eligible to participate in this study of etripamil nasal spray.\u00a0 Participants undergo screening procedures, and are then provided with etripamil to treat episodes of SVT.\u00a0 This is a Phase 3 safety study of an Investigational Product (etripamil).<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT04072835<\/a><\/strong><\/span><\/p>\n

\u00a0<\/h3>\n

NODE-X<\/strong><\/h3>\n

Patients with a history of episodic supraventricular tachycardia (SVT) and who have previously participated in either NODE 301, NODE 302, or NODE 303 are eligible to participate in this extension study of etripamil nasal spray. \u00a0This is a Phase 3 open label extension study of an Investigational Product (etripamil).<\/p>\n

ClinicalTrials.gov Identifier: NCT04952610<\/a><\/span><\/strong><\/p>\n

Health Canada Identifier: Control<\/strong> Number 247598<\/strong><\/span><\/a><\/p>\n

\u00a0<\/h3>\n

OCEAN<\/strong><\/h3>\n

Patients with a history cardiac risk factors and successful ablation for atrial fibrillation are eligible to be randomized to 2 different medications for long-term stroke prevention: Aspirin versus Rivaroxaban (Xarelto).<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT02168829<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

POST 7<\/strong><\/h3>\n

Patients with a history of vasovagal syncope and at least 2 faints in the past year are enrolled and randomized to receive either atomoxetine or placebo for the prevention of future syncopal events.<\/p>\n

ClinicalTrials.gov Identifier:\u00a0NCT05159687<\/a><\/strong><\/span><\/p>\n

RAFT-AF<\/strong><\/h3>\n

Patients with both atrial fibrillation and symptomatic heart failure (NYHA Class 2-3) are eligible to be randomized to either rhythm control (pulmonary vein ablation) or rate control (with medications or AV node ablation) for treatment of atrial fibrillation.<\/p>\n

Enrollment and follow-up of study participants concluded in January 2020.<\/em><\/p>\n

ClinicalTrials.gov Identifier: NCT01420393<\/strong><\/span><\/a><\/p>\n

American College of Cardiology<\/span><\/a><\/strong><\/p>\n

Circulation Results\u00a0<\/a><\/strong><\/span><\/p>\n

 <\/p>\n

RAFT-AF EXTEND<\/strong><\/h3>\n

Patients who participated in the RAFT-AF study are assessed approximately 30 months following their final RAFT-AF study visit. The purpose of the study is to determine whether there is a long-term benefit to patients who received an atrial fibrillation ablation versus rate control during their RAFT-AF participation.<\/p>\n

ClinicalTrials.gov Identifier:\u00a0NCT05118893<\/a><\/strong><\/span><\/p>\n

RAFT-PermAF<\/strong><\/h3>\n

Patients with a history of atrial fibrillation and heart failure who are candidates for ICD implantation are eligible to be randomized to receive 2 different types of devices: single chamber ICD versus cardiac resynchronization therapy ICD (CRT-D).<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT01994252<\/a><\/strong><\/span><\/span><\/p>\n

 <\/p>\n

REFINE-ICD<\/strong><\/h3>\n

Patients with a history of heart attack and mildly decreased cardiac function are screened to assess for additional risk factors for future heart rhythm problems.\u00a0 Participants who are found to have these risk factors are eligible to be randomized to risk reduction with medication versus insertion of an ICD.\u00a0 Participants without these risk factors are followed in a registry.<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT00673842<\/a><\/strong><\/span><\/span><\/p>\n

 <\/p>\n

RPM-CIED: ICD<\/strong><\/h3>\n

Patients with an implanted Medtronic or Abbott Implantable Cardioverter-Defibrillator (ICD) are randomized to management of their device either exclusively through remote monitoring versus the current standard of care (in-clinic visits).\u00a0 Patients in the remote monitoring arm use the VIRTUES platform, developed by CANet, to view information about their device reports.<\/p>\n

ClinicalTrials.gov Identifier: NCT03405740<\/strong><\/a><\/span><\/p>\n

C<\/strong>ANet information<\/strong><\/a><\/span><\/p>\n

VIRTUES information<\/strong><\/a><\/span><\/p>\n

 <\/p>\n

RPM-CIED: PPM<\/strong><\/h3>\n

Patients with an implanted Medtronic or Abbott pacemaker are randomized to management of their device either exclusively through remote monitoring versus the current standard of care (in-clinic visits). Patients in the remote monitoring arm use the VIRTUES platform, developed by CANet to view information about their device reports.<\/p>\n

ClinicalTrials.gov Identifier:\u00a0NCT03636230<\/strong><\/a><\/span><\/p>\n

C<\/strong>ANet information<\/strong><\/a><\/span><\/p>\n

VIRTUES information<\/strong><\/a><\/span><\/p>\n

STAR-AF 3<\/strong><\/h3>\n

Patients with a history of symptomatic persistent atrial fibrillation (episodes between 3 months and 3 years in duration) who are undergoing ablation are eligible to be randomized to 3 different methods of ablation.<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier: NCT04428944<\/strong><\/a><\/span><\/p>\n

 <\/p>\n

SyncAV<\/strong><\/h3>\n

Patients with a history of decreased cardiac output who are candidates for cardiac resynchronization therapy devices (CRT-pacemaker or CRT-D) are eligible to be randomized to 2 different device programming methods.<\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT04100148<\/span><\/a><\/strong><\/span><\/p>\n

 <\/p>\n

VANISH 2<\/strong><\/h3>\n

Patients with a history of heart attack and ventricular tachycardia who either have or will be receiving an ICD are eligible to be randomized to 2 different treatment arms for prevention of future arrhythmias: medication with antiarrhythmic drugs versus ablation treatment.<\/p>\n

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.<\/em><\/p>\n

ClinicalTrials.gov\u00a0<\/span>Identifier:\u00a0NCT02830360<\/a><\/strong><\/span><\/span><\/p>\n

 <\/p>\n

Return to top<\/strong><\/span><\/a><\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”Completed Research” open_toggle_text_color=”#000000″ closed_toggle_text_color=”#000000″ icon_color=”#0400f0″ use_icon_font_size=”on” icon_font_size=”20px” open_icon_color=”#0400f0″ open_use_icon_font_size=”on” open_icon_font_size=”20px” disabled_on=”off|on|on” admin_label=”Completed Research” _builder_version=”4.21.0″ _module_preset=”default” title_text_color=”#000000″ title_font=”|700|||||||” closed_title_font=”|700|||||||” body_text_color=”#000000″ text_orientation=”justified” overflow-x=”scroll” global_colors_info=”{}”]<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Project Name<\/strong><\/td>\nSponsor<\/strong><\/td>\nSummary<\/strong><\/td>\nYear Project Closed<\/strong><\/td>\nFor More Information…<\/strong><\/td>\n<\/tr>\n
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction<\/strong><\/td>\nWyeth Research (now an owned subsidiary of Pfizer)<\/td>\n\n

The purpose of this study was to learn the effects of a test drug (GAP-486) on heart rhythms which may become life-threatening if left untreated (Ventricular Tachyarrhythmia), and to provide data to see if the drug was well tolerated and safe.<\/p>\n

Results: The study was terminated early due to lack of drug efficacy.<\/p>\n<\/td>\n

2006<\/td>\nClinicalTrials.gov Identifier NCT00137332<\/a><\/td>\n<\/tr>\n
ACT ICardiome Pharma Corp (now Advanz Pharma)<\/strong><\/td>\n\u00a0<\/td>\n\n

This study was conducted to demonstrate the effectiveness of investigational drug RSD1235 (vernakalant) in the conversion of atrial fibrillation to sinus rhythm.<\/p>\n

Results: Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.<\/p>\n<\/td>\n

2004<\/td>\nClinicalTrials.gov Identifier NCT00468767<\/a>
<\/a>PubMed.gov Identifier 18332267<\/a><\/td>\n<\/tr>\n
ACT V<\/strong><\/td>\nAstellas Pharma Canada (now Advanz Pharma)<\/td>\n\n

The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.<\/p>\n

A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045) (ACT V).<\/p>\n

Results: Vernakalant resulted in rapid cardioversion of recent-onset AF in almost half of the study population and was generally well tolerated. The safety outcomes affirmed the need for careful selection and management of haemodynamically stable candidates for cardioversion.<\/p>\n<\/td>\n

2010<\/td>\n\n

ClinicalTrials.gov Identifier NCT00989001<\/a><\/p>\n

PubMed.gov Identifier 27233239<\/a><\/p>\n<\/td>\n<\/tr>\n

ACTIVE A<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack, or left ventricular dysfunction etc.<\/p>\n

Results: In patients with atrial fibrillation for whom vitamin K-antagonist therapy was unsuitable, the addition of clopidogrel to aspirin reduced the risk of major vascular events, especially stroke, and increased the risk of major hemorrhage.<\/p>\n<\/td>\n

2009<\/td>\n\n

ClinicalTrials.gov Identifier NCT00249873<\/a><\/p>\n

PubMed.gov Identifier 19336502<\/a><\/p>\n<\/td>\n<\/tr>\n

ACTIVE I<\/strong><\/td>\nSanofi<\/td>\n\n

\u00a0The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.<\/p>\n

Results: Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation.<\/p>\n<\/td>\n

2009<\/td>\n\n

ClinicalTrials.gov Identifier NCT00249795<\/a><\/p>\n

PubMed.gov Identifier\u00a021388310<\/a><\/p>\n<\/td>\n<\/tr>\n

ADAPTIVE CRT (aCRT)<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study is to demonstrate the Medtronic AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance.<\/p>\n

Results: Higher percent synchronized Left Ventricular Pacing (sLVP)\u00a0 was independently associated with superior clinical outcomes. In patients with normal AV conduction, the aCRT algorithm provided mostly sLVP and demonstrated better clinical outcomes compared to the control (echocardiography-optimized Bi-Ventricular Pacing, BVP).<\/p>\n<\/td>\n

2012<\/td>\n\n

ClinicalTrials.gov Identifier NCT00980057<\/a><\/p>\n

PubMed.gov Identifier 23851059<\/a><\/p>\n<\/td>\n<\/tr>\n

ADONIS<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation\/atrial flutter (AF\/AFL), to assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF\/AFL recurrence, and to assess the efficacy of dronedarone versus placebo on AF\/AFL-related symptoms.<\/p>\n

Results: Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.<\/p>\n<\/td>\n

2003<\/td>\n\n

ClinicalTrials.gov Identifier NCT00259376<\/a><\/p>\n

PubMed.gov Identifier 17804843<\/a><\/p>\n<\/td>\n<\/tr>\n

ADVICE<\/strong><\/td>\nMontreal Heart Institute<\/td>\n\n

The primary objective of the ADVICE trial was to evaluate the impact of adenosine-guided Pulmonary Vein Isolation (PVI) in preventing Atrial Fibrillation (AF) recurrences among patients with paroxysmal AF. We hypothesize that a PVI ablation strategy that incorporates elimination of dormant conduction unmasked by intravenous adenosine will decrease symptomatic AF recurrence compared to standard PVI, without incurring significant additional risk.<\/p>\n

Results: Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation. This approach should be considered for incorporation into routine clinical practice.<\/p>\n<\/td>\n

2013<\/td>\n\n

ClinicalTrials.gov Identifier NCT01058980<\/a><\/p>\n

PubMed.gov Identifier 26211828<\/a><\/p>\n<\/td>\n<\/tr>\n

AF-CHF<\/strong><\/td>\nMontreal Heart Institute<\/td>\n\n

Congestive heart failure (CHF) and atrial fibrillation (AF) are two important and growing problems in medicine and cardiology. Both conditions often co-exist and complicate each other’s management. Two therapeutic strategies are available for patients with AF and CHF: the first aims at restoring and maintaining sinus rhythm, whereas, the second focuses exclusively on optimizing ventricular rate. The primary objective of the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is to compare these two widely-used treatment strategies with respect to cardiovascular mortality.<\/p>\n

Results: In patients with atrial fibrillation and congestive heart failure, a routine strategy of rhythm control does not reduce the rate of death from cardiovascular causes, as compared with a rate-control strategy.<\/p>\n<\/td>\n

2007<\/td>\n\n

ClinicalTrials.gov Identifier NCT00597077<\/a><\/p>\n

PubMed.gov Identifier 18565859<\/a><\/p>\n<\/td>\n<\/tr>\n

ALPHEE<\/strong><\/td>\nSanofi<\/td>\n\n

The Primary objective was to assess the efficacy and safety of a new antiarrhythmic agent, Celivarone, for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.<\/p>\n

Results: Celivarone was not effective for the prevention of ICD interventions or sudden death.<\/p>\n<\/td>\n

2011<\/td>\n\n

ClinicalTrials.gov Identifier NCT00993382<\/a><\/p>\n

PubMed.gov Identifier 22082672<\/a><\/p>\n<\/td>\n<\/tr>\n

AMADEUS<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 (idraparinux), compared withvitamin K antagonist tablets (warfarin or acenocoumarol tablets) in patients with atrial fibrillation and risk for clots.<\/p>\n

Results: In patients with atrial fibrillation at risk for thromboembolism, long-term treatment with idraparinux was no worse than vitamin K antagonists in terms of efficacy, but caused significantly more bleeding.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier NCT00070655<\/a><\/p>\n

PubMed.gov Identifier 18294998<\/a><\/p>\n<\/td>\n<\/tr>\n

Amiodarone Aqueous I.V. Injection – Protocol # 0585K1-312-CA<\/strong><\/td>\nWyeth-Ayerst Research and Wyeth-Ayerst Canada Inc.<\/td>\n\n

The purpose of this study was to collect safety information about 2 forms of the drug intravenous (I.V.) amiodarone.\u00a0 One form of amiodarone (Cordarone I.V.) was approved for marketing in 1995 for treatment of ventricular fibrillation and ventricular tachycardia.\u00a0 The other form of amiodarone (Amiodarone Aqueous I.V.) is currently being investigated.<\/p>\n

Results: Wyeth-Ayerst decided to terminate this study after an interim analysis has indicated that the investigational aqueous formulation was associated with a higher incidence of phlebitis (inflammation of a vein) as compared with Cordarone IV.<\/p>\n<\/td>\n

2002<\/td>\nWyeth-Ayerst<\/a><\/td>\n<\/tr>\n
ARISTOTLE<\/strong><\/td>\nBristol-Myers Squibb<\/td>\n\n

The purpose of this trial was to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.<\/p>\n

Results: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.<\/p>\n<\/td>\n

2011<\/td>\n\n

ClinicalTrials.gov Identifier NCT00412984<\/a><\/p>\n

PubMed.gov Identifier 21870978<\/a><\/p>\n<\/td>\n<\/tr>\n

ASPECT AT500<\/strong><\/td>\nMedtronic<\/td>\n\n

The objective of this study will be to use specific atrial lead placement to investigate the efficacy of the atrial arrhythmia prevention pacing features.\u00a0 Lead placement sites will include septal and non-septal atrial pacing sites.<\/p>\n

Results: The combination of three atrial prevention pacing algorithms did not decrease device classified atrial tachyarrhythmia frequency or burden during a 3-month cross-over period in bradycardic patients and septal or nonseptal atrial pacing leads. Prevention pacing was associated with decreased frequency of premature atrial contractions and with decreased symptomatic atrial tachyarrhythmia frequency in patients with atrial septal leads.<\/p>\n<\/td>\n

2003<\/td>\nPubMed.gov Identifier 14678133<\/a><\/td>\n<\/tr>\n
ASSERT<\/strong><\/td>\nSt Jude Medical<\/td>\n\n

The purpose of the study was to determine whether the detection of AHRE (atrial high rate episodes) with pacemaker telemetry predicts an increased risk of stroke in elderly hypertensive patients without prior AF and to determine whether the AF Suppression Algorithm reduces the risk of development of symptomatic AF in elderly hypertensive patients without prior AF receiving a pacemaker for sinus or AV node disease.<\/p>\n

Results: Subclinical atrial tachyarrhythmias, without clinical atrial fibrillation, occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism.<\/p>\n<\/td>\n

2012<\/td>\nNew England Journal of Medicine article<\/a><\/td>\n<\/tr>\n
ASSERT-II<\/strong><\/td>\nPopulation Health Research Institute<\/td>\n\n

The primary objective of the study was to determine the rate of detection of sub-clinical atrial fibrillation (\u2265 5 minutes)within an average of 12 months following implant of the St. Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF.<\/p>\n

Results: SCAF is frequently detected by continuous electrocardiographic monitoring in older patients without a history of atrial fibrillation who are attending outpatient cardiology and neurology clinics. Its clinical significance is unclear.<\/p>\n<\/td>\n

2016<\/td>\n\n

ClinicalTrials.gov Identifier NCT01694394<\/a><\/p>\n

PubMed.gov Identifier 28778946<\/a><\/p>\n<\/td>\n<\/tr>\n

ATHENA<\/strong><\/td>\nSanofi<\/td>\n\n

A placebo-controlled, double-blind, parallel arm trial to assess the efficacy of Dronedarone 400mg po BID to prevent cardiovascular hospitalization or death from any cause in patients with atrial fibrillation\/ atrial flutter.<\/p>\n

Results:\u00a0 Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.<\/p>\n<\/td>\n

2008<\/td>\n\n

ClinicalTrials.gov Identifier NCT00174785<\/a><\/p>\n

PubMed.gov Identifier 19213680<\/a><\/p>\n<\/td>\n<\/tr>\n

BRUISE CONTROL<\/strong><\/td>\nOttawa Heart Institute Research Corporation<\/td>\n\n

The purpose of this study wass to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery.<\/p>\n

Results: As compared with bridging therapy with heparin, a strategy of continued warfarin treatment at the time of pacemaker or ICD surgery markedly reduced the incidence of clinically significant device-pocket hematoma.<\/p>\n<\/td>\n

2013<\/td>\n\n

ClinicalTrials.gov Identifier NCT00800137<\/a><\/p>\n

PubMed.gov Identifier 23659733<\/a><\/p>\n<\/td>\n<\/tr>\n

BRUISE CONTROL 2<\/strong><\/td>\nOttawa Heart Institute Research Corporation<\/td>\n\n

The purpose of this study was to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesized that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.<\/p>\n

Results: These results suggest that, dependent on the clinical scenario, either management strategy (continued DOAC or interrupted DOAC) might be reasonable, at least for patients similar to those enrolled in our trial.<\/p>\n<\/td>\n

2018<\/td>\n\n

ClinicalTrials.gov Identifier NCT01675076<\/a><\/p>\n

PubMed.gov Identifier 30462279<\/a><\/p>\n<\/td>\n<\/tr>\n

CART-HF<\/strong><\/td>\nGuidant, Inc. (now part of Boston Scientific Corporation)<\/td>\n\n

This study analyzed resource utilization and related costs associated with CHF for patients who receive standard implantable cardiac defibrillators (ICDs) versus those who receive ICD plus biventricular pacing or cardiac resynchronization therapy (CRT).<\/p>\n

Results: These analyses indicate that savings in post-implant health-care utilization (hospitalizations and pharmacological therapy) can offset some of the device and procedural costs associated with CRT devices.<\/p>\n<\/td>\n

2007<\/td>\nPubMed.gov Identifier 17241313<\/a><\/td>\n<\/tr>\n
CIRCA-DOSE<\/strong><\/td>\nUniversity of British Columbia<\/td>\n\n

Patients with paroxysmal AF were randomized to either radiofrequency ablation, cryoablation 2 min, or cryoablation 4 min for reduction in recurrent arrhythmias.<\/p>\n

Results: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring.<\/p>\n<\/td>\n

2019<\/td>\n\n

ClinicalTrials.gov Identifier NCT01913522<\/a><\/p>\n

PubMed.gov Identifier 31630538<\/a><\/p>\n

Heart Rhythm Journal article<\/a><\/p>\n<\/td>\n<\/tr>\n

CO1<\/strong><\/td>\nBiosense Webster, Inc.<\/td>\n\n

The purpose of this study was to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO\u00ae 3 or the NavX(TM) System.<\/p>\n

Results: This study was terminated early due to enrollment challenges.<\/p>\n<\/td>\n

2010<\/td>\nClinicalTrials.gov Identifier NCT01036724<\/a><\/td>\n<\/tr>\n
CONTAK CD and TR: Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure<\/strong><\/td>\nGuidant, Inc. (now part of Boston Scientific Corporation)<\/td>\n\n

The purpose of this study was to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular pacing with defibrillation.<\/p>\n

Results: In patients with advanced heart failure and a prolonged QRS interval, cardiac-resynchronization therapy decreases the combined risk of death from any cause or first hospitalization and, when combined with an implantable defibrillator, significantly reduces mortality.<\/p>\n<\/td>\n

2002<\/td>\n\n

ClinicalTrials.gov Identifier NCT00180258<\/a><\/p>\n

PubMed.gov Identifier 15152059<\/a><\/p>\n<\/td>\n<\/tr>\n

CORONA: Models 4074\/4574<\/strong>
Transvenous Steroid Eluting Pacing Leads Study<\/strong><\/td>\n		Medtronic Inc.<\/td>\n\n

This study assessed the safety and performance of the ventricular Model 4074 and atrial Model 4574 pacing leads. All patients had a clinical indication for a dual chamber pacemaker implant.<\/p>\n

Results: Model 4074 ventricular lead and Model 4574 atrial lead were approved for use.<\/p>\n<\/td>\n

2001<\/td>\n\n

Medtronic Lead 4074<\/a><\/p>\n

Medtronic Lead 4574<\/a><\/p>\n<\/td>\n<\/tr>\n

CORYFEE<\/strong><\/td>\nSanofi<\/td>\n\n

This was a double-blind study to assess versus placebo the efficacy of investigational antiarrhythmic drug SSR149744C (celivarone) for the conversion of atrial fibrillation\/flutter to sinus rhythm at the time of a planned electrical cardioversion.<\/p>\n

Results: In these studies, celivarone does not appear to be efficacious in the maintenance of sinus rhythm in AF\/AFL patients or for the conversion of AF\/AFL patients.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier NCT00232310<\/a><\/p>\n

PubMed.gov Identifier 22171925<\/a><\/p>\n<\/td>\n<\/tr>\n

CREDIT<\/strong><\/td>\nGuidant, Inc. (now part of Boston Scientific Corporation)<\/td>\n\n

Canadian Registry of ICD Implant Testing Procedures.\u00a0 The purpose of this registry was to document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.<\/p>\n

Results: Defibrillation testing was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.<\/p>\n<\/td>\n

2008<\/td>\nClinicalTrials.gov Identifier NCT00848341<\/a>
<\/a>
Journal of Cardiovascular Electrophysiology article<\/a><\/td>\n<\/tr>\n
CREDO<\/strong><\/td>\nAbbott Canada<\/td>\n\n

Canadian Registry of Cardiac Implantable Electronic Device Outcomes.\u00a0 This prospective observational study included patients with an Abbott device subject to the advisory, from 9 centres in Canada. The incidence and outcomes related to device revision owing to premature battery depletion were identified and adjudicated by a committee.<\/p>\n

Results: The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low.\u00a0 With the current practice of active surveillance, vibratory alert and remote monitoring, and a novel battery monitoring system, no clinical adverse events associated with PBD were found.\u00a0 This study reaffirms the Abbott reports on the incidence of this advisory and did not find any evidence of adverse clinical events, supporting the current Canadian Heart Rhythm Society recommendations of enhanced monitoring, without the need for early device replacement.<\/p>\n<\/td>\n

2019<\/td>\nCJC Open article<\/a><\/td>\n<\/tr>\n
CTAF-2<\/strong><\/td>\nMontreal Heart Institute<\/td>\n\n

The purpose of this study was to determine the efficacy of 8 mg\/day oral perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential hypertension.<\/p>\n

Results: Perindopril does not reduce recurrence or the number of AF episodes in patients with hypertension and AF.<\/p>\n<\/td>\n

2015<\/td>\n\n

ClinicalTrials.gov Identifier NCT00461903<\/a><\/p>\n

CJC Open article<\/a><\/p>\n<\/td>\n<\/tr>\n

DEFEAT-HF<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure (HF).<\/p>\n

Results: The present study does not provide evidence to support a meaningful change in clinical outcomes for HF patients receiving SCS.<\/p>\n<\/td>\n

2015<\/td>\n\n

ClinicalTrials.gov Identifier NCT01112579<\/a><\/p>\n

PubMed.gov Identifier 26682789<\/a><\/p>\n<\/td>\n<\/tr>\n

DINAMIT<\/strong><\/td>\nSt Jude Medical (now Abbott Medical Devices)<\/td>\n\n

The purpose of this research study was to test whether or not the automatic implantable defibrillator (ICD) helps patients who have had a recent heart attack (myocardial infarction) live longer by preventing cardiac arrest.<\/p>\n

Results: Prophylactic ICD therapy does not reduce overall mortality in high-risk patients who have recently had a myocardial infarction. Although ICD therapy was associated with a reduction in the rate of death due to arrhythmia, that was offset by an increase in the rate of death from nonarrhythmic causes.<\/p>\n<\/td>\n

2004<\/td>\n\n

New England Journal of Medicine article<\/a><\/p>\n

PubMed.gov Identifier 15590950<\/a><\/p>\n<\/td>\n<\/tr>\n

DISCERN AF<\/strong><\/td>\nOttawa Heart Institute Research Corporation<\/td>\n\n

The purpose of this study was to assess the amount of Atrial Fibrillation (AF) that occurs before and after an ablation procedure associated with symptoms versus AF that is not associated with any symptoms.\u00a0 This study sought to confirm whether patients’ symptoms or lack of symptoms post-ablation correlate well with actual episodes of AF.<\/p>\n

Results: The ratio of asymptomatic to symptomatic AF episodes increased from 1.1 before to 3.7 after ablation.\u00a0 Postablation state is the strongest predictor of asymptomatic AF.\u00a0 Symptoms alone underestimate postablation AF burden, with 12% of patients having asymptomatic recurrences only.<\/p>\n<\/td>\n

2014<\/td>\n\n

ClinicalTrials.gov Identifier NCT00745706<\/a><\/p>\n

PubMed.gov Identifier 23266597<\/a><\/p>\n<\/td>\n<\/tr>\n

DUO-FLAIR<\/strong><\/td>\nSt Jude Medical Inc (now Abbott Medical Devices)<\/td>\n\n

The purpose of the study was to demonstrate the safety and efficacy of the use of the new St Jude Therapy Cool Path Duo\u2122 cardiac ablation system for the treatment of typical atrial flutter (cavotricuspid isthmus dependent).<\/p>\n

Results: Cool Path Duo\u2122 irrigated tip catheter is safe and effective in treating typical atrial flutter.\u00a0 When compared to a six-hole irrigated tip catheter, the Cool Path Duo catheter delivers more power at a lower temperature.<\/p>\n<\/td>\n

2013<\/td>\nJournal of Interventional Cardiac Electrophysiology article<\/a><\/td>\n<\/tr>\n
ELECTION<\/strong><\/td>\nGuidant Corporation (now part of Boston Scientific Corporation)<\/td>\n\n

This study served to evaluate the benefits of having various pace\/sense electrode configurations available in a cardiac resynchronization therapy (CRT) system from Guidant.<\/p>\n

Results: Electronic repositioning is an important tool in the management of CRT patients which may help to lower thresholds, avoid phrenic nerve stimulation, and prevent unnecessary re-operations for lead repositioning.<\/p>\n<\/td>\n

2008<\/td>\n\n

ClinicalTrials.gov Identifier NCT00848653<\/a><\/p>\n

PubMed.gov Identifier 21273196<\/a><\/p>\n<\/td>\n<\/tr>\n

ELECTRA<\/strong><\/td>\nSanofi<\/td>\n\n

The purpose of this study was to determine whether the administration of dronedarone (400 mg twice a day) started 5 to 7 days before and after planned cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of new atrial fibrillation (AF) episodes.<\/p>\n

Results: There is no difference in the AF recurrence rates and other variables between the patients starting dronedarone before cardioversion or after cardioversion.<\/p>\n<\/td>\n

2011<\/td>\n\n

ClinicalTrials.gov Identifier NCT01026090<\/a><\/p>\n

Sanofi<\/a><\/p>\n<\/td>\n<\/tr>\n

EMPIRIC<\/strong><\/td>\nMedtronic Inc.<\/td>\n\n

This trial sought to the hypothesis that the shock-related morbidity of implantable cardioverter defibrillator (ICD) therapy is similar whether patients are treated with a standardized empiric programming regimen for ventricular tachycardia\/ventricular fibrillation (VT\/VF) detection and therapy vs. with a patient-specific, physician-tailored approach.<\/p>\n

Results: Standardized empiric ICD programming for VT\/VF settings is at least as effective as patient-specific, physician-tailored programming, as measured by many clinical outcomes.\u00a0 Simplified and pre-specified ICD programming is possible without an increase in shock-related morbidity.<\/p>\n<\/td>\n

2004<\/td>\n\n

Journal of the American College of Cardiology article<\/a><\/p>\n

FDA News article<\/a><\/p>\n

Current Controlled Trials in Cardiovascular Medicine article<\/a><\/p>\n<\/td>\n<\/tr>\n

EnRhythm MRI<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this clinical study was to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI\u2122 SureScan\u2122 Pacing System by Medtronic (used in support of Revo MRI\u2122 SureScan Pacing System launch).<\/p>\n

Results: This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.<\/p>\n<\/td>\n

2010<\/td>\n\n

ClinicalTrials.gov Identifier NCT00433654<\/a><\/p>\n

PubMed.gov Identifier 19055703<\/a><\/p>\n<\/td>\n<\/tr>\n

FLEXION-AFL<\/strong><\/td>\nSt Jude Medical Inc (now Abbott Medical Devices)<\/td>\n\n

The purpose of this trial was to demonstrate that ablation with the St Jude Therapy\u2122 Cool Flex\u2122 Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.<\/p>\n

Results: The FLEXION AFL pivotal study demonstrated that the Therapy Cool Flex Ablation Catheter met the safety goal and the efficacy performance goal for its intended use as defined in the clinical protocol.\u00a0 As a result, this system was approved for use by the FDA.<\/p>\n<\/td>\n

2012<\/td>\n\n

ClinicalTrials.gov Identifier NCT01408485<\/a><\/p>\n

FDA Approval information<\/a><\/p>\n<\/td>\n<\/tr>\n

Fortify\u2122\/Unify\u2122 New Technology Assessment (NTA)<\/strong><\/td>\nSt Jude Medical International, Inc (now Abbott Medical Devices)<\/td>\n\n

The primary purpose of this study was to evaluate the overall device function and performance of the new Fortify\u2122 implantable cardioverter defibrillator (ICD) and Unity\u2122 ICD with cardiac resynchronization therapy (CRT-D) made by St. Jude Medical, not yet approved by Health Canada.<\/p>\n

Results: These devices are now approved for use.<\/p>\n<\/td>\n

2010<\/td>\nBiospace article<\/a><\/td>\n<\/tr>\n
GEM III<\/strong><\/td>\nMedtronic Inc.<\/td>\n\n

The purpose of this clinical study was to evaluate the safety and effectiveness of the investigational GEM III DR implantable cardioverter defibrillator (ICD), Model 7275, system by Medtronic, used to control heart rhythm problems.<\/p>\n

Results: The GEM III DR ICD was approved for use.<\/p>\n<\/td>\n

2000<\/td>\nMed Device Online article<\/a><\/td>\n<\/tr>\n
GLORIA-AF Registry<\/strong><\/td>\nBoehringer Ingelheim<\/td>\n\n

In these second and third phases of the GLORIA-AF registry program, patients with non-valvular atrial fibrillation (AF) at risk for stroke were enrolled to characterize the target population and to collect real world data on important outcome events.\u00a0 Anticoagulation use was observed and compared.<\/p>\n

Results: GLORIA-AF findings reinforce a favourable benefit-risk profile for anticoagulation with dabigatran (Pradaxa) compared with Vitamin K antagonists (warfarin) in routine clinical practice among patients with newly diagnosed AF.<\/p>\n<\/td>\n

2020<\/td>\n\n

ClinicalTrials.gov Identifier NCT01468701<\/a><\/p>\n

Boehringer Ingelheim<\/a><\/p>\n<\/td>\n<\/tr>\n

ICI COOL PATH<\/strong><\/td>\nIrvine Biomedical, Inc. (a St Jude Medical company)<\/td>\n\n

The purpose of this study was to compare the safety and effectiveness of an investigational ablation catheter (the IBI Therapy Cool Path Ablation Catheter) with approved ablation catheters for the treatment of typical atrial flutter.\u00a0 An investigational device is one that has not been approved by the Food and Drug Administration (FDA) in the United States or the Health Products and Food Branch (HPFB) in Canada.<\/p>\n

Results: The\u00a0 IBI Therapy Cool Path Ablation Catheter was approved for use for treatment of Atrial Flutter in 2007.<\/p>\n<\/td>\n

2007<\/td>\nFDA Report P060019<\/a><\/td>\n<\/tr>\n
ICY AVNRT<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to determine if the Medtronic Freezor\u00ae Xtra Surgical Cardiac CryoAblation catheter (“cryoablation catheter\u201d) is safe and effective for the treatment of a kind of cardiac arrhythmia (atrioventricular nodal reentrant tachycardia – AVNRT).<\/p>\n

Results: Cryoablation for AVNRT using a focal 6-mm catheter was safe and effective. It resulted in a low risk of recurrence over 6 months of follow-up with no incidence of AV block requiring permanent pacing.<\/p>\n<\/td>\n

2016<\/td>\n\n

ClinicalTrials.gov Identifier NCT01426425<\/a><\/p>\n

PubMed.gov Identifier 29044787<\/a><\/p>\n<\/td>\n<\/tr>\n

LEAD LIFE<\/strong><\/td>\nGuidant Corporation (now part of Boston Scientific Corporation)<\/td>\nThe purpose of the LEAD LIFE study was to collect information regarding the
performance of the ENDOTAK ENDURANCE EZ and ENDOTAK RELIANCE family of
transvenous defibrillation leads. This was a prospective, non-randomized, multi-centre, observational clinical study.Results: The LEAD LIFE study demonstrated that the leads were safe and reliable over time.\u00a0 Characterization of implant location, lead selection, and defibrillation testing were consistent across all sites.\u00a0 There were minimal complications and observations in the study.<\/td>\n		2004<\/td>\nClinicalTrials.gov Identifier NCT00848835<\/a><\/td>\n<\/tr>\n
LEARN<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

This was a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design was an observational examination of LV thresholds over time.\u00a0 The Medtronic Concerto CRT-ICD device was used in this study.<\/p>\n

Results: This study demonstrated that the Left Ventricular Capture Management (LVCM) algorithm is safe, accurate, and highly reliable. LVCM worked with different types of leads and different lead locations. LVCM was demonstrated to be clinically equivalent to the manual LV threshold test. LVCM offers automatic measurement, output adaptation, and trends of the LV threshold and should result in improved ability to maintain LV capture without sacrificing device longevity.<\/p>\n<\/td>\n

\u00a0<\/td>\n\n

ClinicalTrials.gov Identifier NCT01089634<\/a><\/p>\n

PubMed.gov Identifier 17897121<\/a><\/p>\n<\/td>\n<\/tr>\n

Long term outcomes following pacemaker implantation and atrioventricular node ablation for management of atrial fibrillation
<\/strong><\/td>\n		VCAT – Academic<\/td>\n\n

The purpose of this retrospective chart review was to determine long-term safety and effectiveness of pacemaker implant plus AV node ablation (“pace and ablate” strategy) for management of atrial fibrillation, and to compare outcomes between patients who undergo both pacemaker implant and AV node ablation on the same day versus on two different days. This study included patients from the Royal Jubilee Hospital in BC and the Sunshine Coast University Hospital in Australia.<\/p>\n

Results: Pacemaker implant and AV node ablation may be performed safely together in a single procedure (i.e. same day) and can potentially lead to improved patient convenience and cost savings.<\/p>\n<\/td>\n

2018<\/td>\nPublished in Heart Lung and Circulation<\/a><\/td>\n<\/tr>\n
MAIA<\/strong><\/td>\nSanofi<\/td>\n\n

Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation\/Flutter (MAIA).<\/p>\n

Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF\/AFL.<\/p>\n

Results: In these studies, celivarone does not appear to be efficacious in the maintenance of sinus rhythm in AF\/AFL patients or for the conversion of AF\/AFL patients.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier NCT00233441<\/a><\/p>\n

PubMed.gov Identifier 22171925<\/a><\/p>\n<\/td>\n<\/tr>\n

MATRIX<\/strong><\/td>\nBiotronik SE & Co. KG<\/td>\n\n

In this registry, patients with no history of atrial fibrillation and who were scheduled to receive a single chamber ICD were implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX (or successor single chamber DX system) to assess if this ICD system effectively and accurately detected atrial fibrillation.<\/p>\n

Results: Pending<\/em><\/p>\n<\/td>\n

2020<\/td>\nClinicalTrials.gov Identifier NCT01774357<\/a><\/td>\n<\/tr>\n
MODEL 4195 Left Ventricular Lead<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also “steroid-eluting” which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.<\/p>\n

Results: This lead was approved for release to US markets in 2008.<\/p>\n<\/td>\n

2006<\/td>\n\n

ClinicalTrials.gov Identifier NCT00269230<\/a><\/p>\n

Medtronic Lead 4195 Attain StarFix<\/a><\/p>\n<\/td>\n<\/tr>\n

MODEL 6949<\/strong><\/td>\nMedtronic, Inc.<\/td>\n\n

The purpose of this registry was to assess the handling and performance of the new Model 6949 lead from Medtronic, Inc (Sprint Fidelis).\u00a0 This lead was used in connection with an ICD system used to control a dangerously fast-beating heart.\u00a0 The Model 6949 lead was investigational at this time, which means it was not yet approved by the Therapeutic Products Directorate (TPD) of Health Canada and was not available to the general public.<\/p>\n

Results: The Model 6469 Sprint Fidelis lead was approved for use.\u00a0 Since this time, there has been an advisory on this lead, though it was not recommended to prophylactically replace the lead.<\/p>\n<\/td>\n

2004<\/td>\n\n

Medtronic Lead 6949 Sprint Fidelis<\/a><\/p>\n

Government of Canada Recall Notice<\/a><\/p>\n<\/td>\n<\/tr>\n

MVP TRIAL<\/strong><\/td>\nMedtronic Cardiac Rhythm and Heart Failure<\/td>\n\n

The purpose of this study was to determine whether atrial pacing with ventricular backup pacing is equivalent to ventricular backup pacing only in implantable cardioverter-defibrillator (ICD) patients.\u00a0 This study compared these two programming options for their effects on how much electrical pulse therapy patients received from the ICD and how frequently they are hospitalized for their heart condition. There were no experimental procedures in this trial.<\/p>\n

Results: This study was terminated due to an inability to reach statistical significance towards the primary endpoint (reduction in all cause mortality and heart failure hospitalizations or urgent care visits).\u00a0 Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated.<\/p>\n<\/td>\n

2009<\/td>\n\n

ClinicalTrials.gov Identifier NCT00281099<\/a><\/p>\n

PubMed.gov Identifier 20685401<\/a><\/p>\n<\/td>\n<\/tr>\n

NODE 302<\/strong><\/td>\nMilestone Pharmaceuticals Inc<\/td>\n\n

The NODE-302 study was an open-label safety extension of the NODE-301 efficacy study. It was a multi-centre, open label study designed to evaluate the safety of etripamil NS 70 mg when self-administered by patients for spontaneous episodes of PSVT in an outpatient setting, and to provide supporting data for the NODE 301 study.<\/p>\n

Results: This study was completed in late 2020 in order to focus on NODE 301. As approval of etripamil depends on the results from NODE 301, results from NODE 302 will contribute to the etripamil NDA safety database.<\/p>\n<\/td>\n

2020<\/td>\nClinicalTrials.gov Identifier\u00a0NCT03635996<\/a><\/td>\n<\/tr>\n
OPTIC<\/strong><\/td>\nSt Jude Medical (now Abbott Medical Devices)<\/td>\n\n

This study was an open parallel design randomized trial of 3 different medication regimes for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation.\u00a0 The 3 medication regimes were: 1- amiodarone plus a beta blocker, 2- a beta blocker alone, and 3- sotalol.\u00a0 The objective was to determine whether amiodarone plus a beta blocker or sotalol were superior to beta blocker alone.<\/p>\n

Results: Amiodarone plus beta-blocker is effective for preventing these shocks and is more effective than sotalol but has an increased risk of drug-related adverse effects.<\/p>\n<\/td>\n

2004<\/td>\n\n

ClinicalTrials.gov Identifier NCT00257959<\/a><\/p>\n

PubMed.gov Identifier 16403928<\/a><\/p>\n<\/td>\n<\/tr>\n

PainFree SST<\/strong><\/td>\nMedtronic, Inc.<\/td>\n\n

Phase 2 of the Safety and Clinical Performance of the Protect ICD and CRT-D study (Phase I: PROTECTA).\u00a0\u00a0 The purpose of the PainFree SmartShock Technology (SST) study was to evaluate the impact of the new SST features in reducing inappropriate ICD shocks.\u00a0 Patients were randomized to either standard detection duration or prolonged detection duration by their ICD; the study question was whether providing more time for rhythm analysis prior to delivery of a shock would allow the ICD to correctly identify and treat the patient’s heart rhythm with greater success.<\/p>\n

Results: In a large patient cohort receiving ICDs for primary or secondary prevention, the adoption of novel enhanced detection algorithms in conjunction with routine implementation of modern programming strategies led to a very low inappropriate shock rate.<\/p>\n<\/td>\n

2014<\/td>\n\n

ClinicalTrials.gov Identifier NCT00982397<\/a><\/p>\n

PubMed.gov Identifier 25637563<\/a><\/p>\n

PubMed.gov Identifier 26988379<\/a><\/p>\n<\/td>\n<\/tr>\n

PALLAS<\/strong><\/td>\nSanofi-Aventis<\/td>\n\n

Patients with a history of atrial fibrillation episodes 6 months or longer and risk factors for major cardiovascular events (such as stroke, heart attack, or cardiovascular death) were randomized to receive an antiarrhythmic drug called dronedarone (also known as Multaq) versus placebo.\u00a0 The objective was to demonstrate the efficacy of dronedarone in preventing these major cardiovascular events, unplanned cardiovascular hospitalizations, or all cause mortality in this patient population.<\/p>\n

Results: This study was stopped for safety purposes.\u00a0 Dronedarone increased rates of heart failure, stroke, and death from cardiovascual causes in this patient population.\u00a0 Dronedarone should not be used in these patients.<\/p>\n<\/td>\n

2012<\/td>\n\n

ClinicalTrials.gov Identifier NCT01151137<\/a><\/p>\n

PubMed.gov Identifier 22082198<\/a><\/p>\n<\/td>\n<\/tr>\n

POST 4<\/strong><\/td>\nUniversity of Calgary<\/td>\n\n

Patients with a history of vasovagal syncope (fainting) were randomized to receive either an investigational medication called Midodrine or a placebo to prevent future episodes of syncope.<\/p>\n

Results: Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden.<\/p>\n<\/td>\n

2020<\/td>\n\n

ClinicalTrials.gov Identifier NCT01456481<\/a><\/p>\n

Annals of Internal Medicine article<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

Clinical research is developed when medical professionals try to expand knowledge of a particular medical condition, treatment, or question.\u00a0 Human volunteers (also called participants or subjects) are required to help answer these important questions and improve medical knowledge. Observational studies\u00a0gather information about participants with a specific condition or diagnosis in order to learn more about […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_robots_primary_cat":"","_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"_links":{"self":[{"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/pages\/137"}],"collection":[{"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/comments?post=137"}],"version-history":[{"count":9,"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/pages\/137\/revisions"}],"predecessor-version":[{"id":1685,"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/pages\/137\/revisions\/1685"}],"wp:attachment":[{"href":"https:\/\/catrials.org\/wp-json\/wp\/v2\/media?parent=137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}