Clinical Research Trials

WHAT IS CLINICAL RESEARCH?

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

Observational studies gather information about participants with a specific condition or diagnosis in order to learn more about their condition, without requiring specific interventions or treatments.  An example of an observational study is a registry where participants’ health records are reviewed every year.

Clinical trials also involve participants with a specific condition or diagnosis, but an intervention or set of interventions are tested to try to improve patient care.  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.  An example of a clinical trial is a study of two different medications being used to treat a condition.

All clinical research conducted at VCAT is reviewed by a Clinical Research Ethics Board (CREB) and must be approved before it can proceed.  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).  The CREB for Vancouver Island is the Island Health Clinical Research Ethics Board.

COVID-19 PANDEMIC

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.  As guidance from Island Health and the Province of BC changes, so too will VCAT’s policies regarding research during the pandemic.  All VCAT team members are vaccinated against COVID-19, as per Island Health requirements.

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.  VCAT tries to mitigate these risks by adhering to local guidelines, but you should be aware of these potential risks.  Island Health has developed notices to inform study participants of these risks.  We invite you to read and review these notices before you decide to participate in any research project at this time.

Island Health Notice for participants in registries/observational trials
(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)

Island Health Notice for participants in interventional trials
(where a specific intervention, such as administration of a certain drug or therapy is required by the study)

COVID-19 PANDEMIC

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.  As guidance from Island Health and the Province of BC changes, so too will VCAT’s policies regarding research during the pandemic.  All VCAT team members are vaccinated against COVID-19, as per Island Health requirements.

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.  VCAT tries to mitigate these risks by adhering to local guidelines, but you should be aware of these potential risks.  Island Health has developed notices to inform study participants of these risks.  We invite you to read and review these notices before you decide to participate in any research project at this time.

Island Health Notice for participants in registries/observational trials
(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)

Island Health Notice for participants in interventional trials
(where a specific intervention, such as administration of a certain drug or therapy is required by the study)

Some of the terms listed may be unfamiliar to you. Please contact our office for more information.

Current Research
Project Name Summary For More Information…
APPRAISE ATP

Patients with a Boston Scientific implantable cardioverter defibrillator (ICD) with decreased cardiac function are eligible to be randomized to 2 different ICD settings.

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov

Identifier: NCT02923726

ARTESiA

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).

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov

Identifier: NCT01938248

ATLAS S-ICD

Patients requiring a single chamber ICD are eligible to be randomized to 2 different types of ICD: transvenous versus subcutaneous.

Enrollment and follow-up of study participants concluded in January 2022; results are currently pending.

ClinicalTrials.gov

Identifier: NCT02881255

AWARE

Patients with a history of episodic (paroxysmal) atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.

Enrollment and follow-up of study participants concluded in October 2021; study results are pending.

ClinicalTrials.gov

Identifier: NCT02150902

CAPLA

Patients with a history of persistent atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ANZCTR.org.au

Identifier: ACTRN12616001436460

CATCH-AF 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).

ClinicalTrials.gov

Identifier: NCT04302311

COAST-AF 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.

ClinicalTrials.gov

Identifier: NCT03347227

DREAM-SICD

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.

Chart review has concluded for this study; publication is currently pending.

Canadian Journal of Cardiology Publication
EARLY-AF

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.

Enrollment and follow-up of study participants concluded in March 2022; overall study results are pending.

ClinicalTrials.gov

Identifier: NCT02825979

Interim Results: New England Journal of Medicine

HiRO Registry 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.  Participants are eligible to complete Biobanking.  This registry includes patients formerly enrolled in CASPERLQT, and ARVC.

ClinicalTrials.gov

Identifier: NCT04189822

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

ClinicalTrials.gov

Identifier: NCT03464019

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

ClinicalTrials.gov

Identifier: NCT04072835

NODE-X 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.  This is a Phase 3 open label extension study of an Investigational Product (etripamil).

ClinicalTrials.gov

Identifier: NCT04952610

Health Canada Identifier: Control Number 247598

OCEAN

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).

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov

Identifier: NCT02168829

RAFT-AF

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.

Enrollment and follow-up of study participants concluded in January 2020.

ClinicalTrials.gov

Identifier: NCT01420393

American College of Cardiology

Circulation Results

RAFT-PermAF 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).

ClinicalTrials.gov

Identifier: NCT01994252

REFINE-ICD 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.  Participants who are found to have these risk factors are eligible to be randomized to risk reduction with medication versus insertion of an ICD.  Participants without these risk factors are followed in a registry.

ClinicalTrials.gov

Identifier: NCT00673842

RPM-CIED: ICD 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).  Patients in the remote monitoring arm use the VIRTUES platform, developed by CANet, to view information about their device reports.

ClinicalTrials.gov

Identifier: NCT03405740

CANet information

VIRTUES information

STAR-AF 3 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.

ClinicalTrials.gov

Identifier: NCT04428944

SyncAV 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.

ClinicalTrials.gov

Identifier: NCT04100148

VANISH 2

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.

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov

Identifier: NCT02830360

Return to top

 

 

Completed Research
Project Name Sponsor Summary Year Project Closed For More Information…
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction Wyeth Research (now an owned subsidiary of Pfizer)

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.

Results: The study was terminated early due to lack of drug efficacy.

2006 ClinicalTrials.gov Identifier: NCT00137332
ABLATOR St Jude Medical International, Inc (now Abbott Medical Devices)

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).  All participants were already planned to undergo an ablation procedure for AF and consented to participate in this observational registry.  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.

Results: 2035 patients signed consent, and 1932 patients received ablation therapy and completed 12 months of follow-up in the study.  Of these 1932 participants, 1297 remained free from atrial arrhythmias at 12 months post-ablation.

2018 ClinicalTrials.gov Identifier: NCT02344173
ACT I Cardiome Pharma Corp (now Advanz Pharma)

This study was conducted to demonstrate the effectiveness of investigational drug RSD1235 (vernakalant) in the conversion of atrial fibrillation to sinus rhythm.

Results: Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.

2004 ClinicalTrials.gov Identifier: NCT00468767
PubMed.gov Identifier: 18332267
ACT V Astellas Pharma Canada (now Advanz Pharma)

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.

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

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.

2010

ClinicalTrials.gov Identifier: NCT00989001

PubMed.gov Identifier: 27233239

ACTIVE A Sanofi

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.

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.

2009

ClinicalTrials.gov Identifier: NCT00249873

PubMed.gov Identifier: 19336502

ACTIVE I Sanofi

 The 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.

Results: Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation.

2009

ClinicalTrials.gov Identifier: NCT00249795

PubMed.gov Identifier: 21388310

ADAPTIVE CRT (aCRT) Medtronic Cardiac Rhythm and Heart Failure

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.

Results: Higher percent synchronized Left Ventricular Pacing (sLVP)  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).

2012

ClinicalTrials.gov Identifier: NCT00980057

PubMed.gov Identifier: 23851059

ADONIS Sanofi

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.

Results: Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.

2003

ClinicalTrials.gov Identifier: NCT00259376

PubMed.gov Identifier: 17804843

ADVICE Montreal Heart Institute

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.

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.

2013

ClinicalTrials.gov Identifier: NCT01058980

PubMed.gov Identifier: 26211828

AF-CHF Montreal Heart Institute

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.

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.

2007

ClinicalTrials.gov Identifier: NCT00597077

PubMed.gov Identifier: 18565859

ALPHEE Sanofi

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.

Results: Celivarone was not effective for the prevention of ICD interventions or sudden death.

2011

ClinicalTrials.gov Identifier: NCT00993382

PubMed.gov Identifier: 22082672

AMADEUS Sanofi

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.

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.

2006

ClinicalTrials.gov Identifier: NCT00070655

PubMed.gov Identifier: 18294998

Amiodarone Aqueous I.V. Injection – Protocol # 0585K1-312-CA Wyeth-Ayerst Research and Wyeth-Ayerst Canada Inc.

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

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.

2002 Wyeth-Ayerst
ARISTOTLE Bristol-Myers Squibb

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.

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.

2011

ClinicalTrials.gov Identifier: NCT00412984

PubMed.gov Identifier: 21870978

ASPECT AT500 Medtronic

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

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.

2003 PubMed.gov Identifier 14678133
ASSERT St Jude Medical (now Abbott Medical Devices)

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.

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.

2012 New England Journal of Medicine article
ASSERT-II Population Health Research Institute

The primary objective of the study was to determine the rate of detection of sub-clinical atrial fibrillation (≥ 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.

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.

2016

ClinicalTrials.gov Identifier: NCT01694394

PubMed.gov Identifier: 28778946

ATHENA Sanofi

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.

Results: Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.

2008

ClinicalTrials.gov Identifier: NCT00174785

PubMed.gov Identifier: 19213680

BRUISE CONTROL Ottawa Heart Institute Research Corporation

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.

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.

2013

ClinicalTrials.gov Identifier: NCT00800137

PubMed.gov Identifier: 23659733

BRUISE CONTROL 2 Ottawa Heart Institute Research Corporation

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.

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.

2018

ClinicalTrials.gov Identifier: NCT01675076

PubMed.gov Identifier: 30462279

CART-HF Guidant, Inc. (now part of Boston Scientific Corporation)

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).

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.

2007 PubMed.gov Identifier: 17241313
CIRCA-DOSE University of British Columbia

Patients with paroxysmal AF were randomized to either radiofrequency ablation, cryoablation 2 min, or cryoablation 4 min for reduction in recurrent arrhythmias.

Results: 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.

2019

ClinicalTrials.gov Identifier: NCT01913522

PubMed.gov Identifier: 31630538

Heart Rhythm Journal article

CO1 Biosense Webster, Inc.

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® 3 or the NavX(TM) System.

Results: This study was terminated early due to enrollment challenges.

2010 ClinicalTrials.gov Identifier: NCT01036724
CONTAK CD and TR: Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure Guidant, Inc. (now part of Boston Scientific Corporation)

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.

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.

2002

ClinicalTrials.gov Identifier: NCT00180258

PubMed.gov Identifier: 15152059

CORONA: Models 4074/4574
Transvenous Steroid Eluting Pacing Leads Study
Medtronic Inc.

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.

Results: Model 4074 ventricular lead and Model 4574 atrial lead were approved for use.

2001

Medtronic Lead 4074

Medtronic Lead 4574

CORYFEE Sanofi

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.

Results: 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.

2006

ClinicalTrials.gov Identifier: NCT00232310

PubMed.gov Identifier: 22171925

CREDIT Guidant, Inc. (now part of Boston Scientific Corporation)

Canadian Registry of ICD Implant Testing Procedures.  The purpose of this registry was to document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Results: Defibrillation testing was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.

2008 ClinicalTrials.gov Identifier: NCT00848341

Journal of Cardiovascular Electrophysiology article
CREDO Abbott Canada

Canadian Registry of Cardiac Implantable Electronic Device Outcomes.  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.

Results: The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low.  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.  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.

2019 CJC Open article
CTAF-2 Montreal Heart Institute

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.

Results: Perindopril does not reduce recurrence or the number of AF episodes in patients with hypertension and AF.

2015

ClinicalTrials.gov Identifier: NCT00461903

CJC Open article

DEFEAT-HF Medtronic Cardiac Rhythm and Heart Failure

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

Results: The present study does not provide evidence to support a meaningful change in clinical outcomes for HF patients receiving SCS.

2015

ClinicalTrials.gov Identifier: NCT01112579

PubMed.gov Identifier: 26682789

DINAMIT St Jude Medical (now Abbott Medical Devices)

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.

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 non-arrhythmic causes.

2004

New England Journal of Medicine article

PubMed.gov Identifier: 15590950

DISCERN AF Ottawa Heart Institute Research Corporation

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.  This study sought to confirm whether patients’ symptoms or lack of symptoms post-ablation correlate well with actual episodes of AF.

Results: The ratio of asymptomatic to symptomatic AF episodes increased from 1.1 before to 3.7 after ablation.  Post-ablation state is the strongest predictor of asymptomatic AF.  Symptoms alone underestimate post-ablation AF burden, with 12% of patients having asymptomatic recurrences only.

2014

ClinicalTrials.gov Identifier: NCT00745706

PubMed.gov Identifier: 23266597

DUO-FLAIR St Jude Medical Inc (now Abbott Medical Devices)

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

Results: Cool Path Duo™ irrigated tip catheter is safe and effective in treating typical atrial flutter.  When compared to a six-hole irrigated tip catheter, the Cool Path Duo catheter delivers more power at a lower temperature.

2013 Journal of Interventional Cardiac Electrophysiology article
ELECTION Guidant Corporation (now part of Boston Scientific Corporation)

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

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.

2008

ClinicalTrials.gov Identifier: NCT00848653

PubMed.gov Identifier: 21273196

ELECTRA Sanofi

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.

Results: There is no difference in the AF recurrence rates and other variables between the patients starting dronedarone before cardioversion or after cardioversion.

2011

ClinicalTrials.gov Identifier: NCT01026090

Sanofi

EMPIRIC Medtronic Inc.

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.

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.  Simplified and pre-specified ICD programming is possible without an increase in shock-related morbidity.

2004

Journal of the American College of Cardiology article

FDA News article

Current Controlled Trials in Cardiovascular Medicine article

EnRhythm MRI Medtronic Cardiac Rhythm and Heart Failure

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™ SureScan™ Pacing System by Medtronic (used in support of Revo MRI™ SureScan Pacing System launch).

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.

2010

ClinicalTrials.gov Identifier: NCT00433654

PubMed.gov Identifier: 19055703

FLEXION-AFL St Jude Medical Inc (now Abbott Medical Devices)

The purpose of this trial was to demonstrate that ablation with the St Jude Therapy™ Cool Flex™ 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.

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.  As a result, this system was approved for use by the FDA.

2012

ClinicalTrials.gov Identifier: NCT01408485

FDA Approval information

Fortify™/Unify™ New Technology Assessment (NTA) St Jude Medical International, Inc (now Abbott Medical Devices)

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

Results: These devices are now approved for use.

2010 Biospace article
GEM III Medtronic Inc.

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.

Results: The GEM III DR ICD was approved for use.

2000 Med Device Online article
GLORIA-AF Registry Boehringer Ingelheim

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.  Anticoagulation use was observed and compared.

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.

2020

ClinicalTrials.gov Identifier: NCT01468701

Boehringer Ingelheim

ICI COOL PATH Irvine Biomedical, Inc. (a St Jude Medical company)

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.  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.

Results: The IBI Therapy Cool Path Ablation Catheter was approved for use for treatment of Atrial Flutter in 2007.

2007 FDA Report P060019
ICY AVNRT Medtronic Cardiac Rhythm and Heart Failure

The purpose of this study was to determine if the Medtronic Freezor® Xtra Surgical Cardiac CryoAblation catheter (“cryoablation catheter”) is safe and effective for the treatment of a kind of cardiac arrhythmia (atrioventricular nodal reentrant tachycardia – AVNRT).

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.

2016

ClinicalTrials.gov Identifier: NCT01426425

PubMed.gov Identifier: 29044787

LEAD LIFE Guidant Corporation (now part of Boston Scientific Corporation)

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.

Results: The LEAD LIFE study demonstrated that the leads were safe and reliable over time.  Characterization of implant location, lead selection, and defibrillation testing were consistent across all sites.  There were minimal complications and observations in the study.

2004 ClinicalTrials.gov Identifier: NCT00848835
LEARN Medtronic Cardiac Rhythm and Heart Failure

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.  The Medtronic Concerto CRT-ICD device was used in this study.

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.

 

ClinicalTrials.gov Identifier: NCT01089634

PubMed.gov Identifier: 17897121

Long term outcomes following pacemaker implantation and atrioventricular node ablation for management of atrial fibrillation
VCAT – Academic

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.

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.

2018 Heart Lung and Circulation
MAIA Sanofi

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.  The purpose of this study was to evaluate the efficacy and tolerability of 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.

Results: In this study, celivarone did not appear to be efficacious in the maintenance of sinus rhythm in atrial fibrillation or atrial flutter patients or for the conversion of atrial fibrillation or atrial flutter patients.

2006

ClinicalTrials.gov Identifier: NCT00233441

PubMed.gov Identifier: 22171925

MATRIX Biotronik SE & Co. KG

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.

Results: Pending

2020 ClinicalTrials.gov Identifier: NCT01774357
MODEL 4195 Left Ventricular Lead Medtronic Cardiac Rhythm and Heart Failure

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.

Results: This lead was approved for release to US markets in 2008.

2006

ClinicalTrials.gov Identifier: NCT00269230

Medtronic Lead 4195 Attain StarFix

MODEL 6949 Medtronic, Inc.

The purpose of this registry was to assess the handling and performance of the new Model 6949 lead from Medtronic, Inc (Sprint Fidelis).  This lead was used in connection with an ICD system used to control a dangerously fast-beating heart.  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.

Results: The Model 6469 Sprint Fidelis lead was approved for use.  Since this time, there has been an advisory on this lead, though it was not recommended to prophylactically replace the lead.

2004

Medtronic Lead 6949 Sprint Fidelis

Government of Canada Recall Notice

MVP TRIAL Medtronic Cardiac Rhythm and Heart Failure

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.  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.

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).  Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated.

2009

ClinicalTrials.gov Identifier: NCT00281099

PubMed.gov Identifier: 20685401

NODE 302 Milestone Pharmaceuticals Inc

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.

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.

2020 ClinicalTrials.gov Identifier: NCT03635996
OPTIC St Jude Medical (now Abbott Medical Devices)

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.  The 3 medication regimes were: 1- amiodarone plus a beta blocker, 2- a beta blocker alone, and 3- sotalol.  The objective was to determine whether amiodarone plus a beta blocker or sotalol were superior to beta blocker alone.

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.

2004

ClinicalTrials.gov Identifier: NCT00257959

PubMed.gov Identifier: 16403928

PainFree SST Medtronic, Inc.

Phase 2 of the Safety and Clinical Performance of the Protect ICD and CRT-D study (Phase I: PROTECTA).   The purpose of the PainFree SmartShock Technology (SST) study was to evaluate the impact of the new SST features in reducing inappropriate ICD shocks.  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.

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.

2014

ClinicalTrials.gov Identifier: NCT00982397

PubMed.gov Identifier: 25637563

PubMed.gov Identifier: 26988379

PALLAS Sanofi-Aventis

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.  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.

Results: This study was stopped for safety purposes.  Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in this patient population.  Dronedarone should not be used in these patients.

2012

ClinicalTrials.gov Identifier: NCT01151137

PubMed.gov Identifier: 22082198

POST 4 University of Calgary

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.

Results: Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden.

2020

ClinicalTrials.gov Identifier: NCT01456481

Annals of Internal Medicine article

RE-CIRCUIT Boehringer Ingelheim

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.  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.  Patients received either dabigatran 150 mg twice daily or warfarin as needed to maintain an INR between 2.0 and 3.0.

Results: In patients undergoing ablation for atrial fibrillation, anticoagulation with uninterrupted dabigatran was associated with fewer bleeding complications than uninterrupted warfarin.

2017

ClinicalTrials.gov Identifier: NCT02348723

PubMed.gov Identifier: 28317415

Scene 2Cardiome Pharma Corp (now Advanz Pharma)  

This study attempted to demonstrate the effectiveness of investigational drug RSD1235 (vernakalant) in the conversion of atrial flutter (AFL) to sinus rhythm.

Results: Vernakalant did not restore sinus rhythm in patients with AFL. Vernakalant modestly slowed AFL and ventricular response rates, and was well tolerated.

2004

ClinicalTrials.gov Identifier: NCT00476112

PubMed.gov Identifier: 22291438

SHIELD-2 Forest Laboratories

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).

Results: This study was terminated early due to Sponsor funding withdrawal.  The SHIELD-2 trial was statistically underpowered due to early trial termination and did not meet its primary objective.  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.

2013

ClinicalTrials.gov Identifier: NCT01464476

American Heart Journal article

SPRITELY University of Calgary

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.  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.

Results: 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.  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).

2017

ClinicalTrials.gov Identifier: NCT01423994

PubMed.gov Identifier: 35210082

X-VERT Bayer

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.

Results: Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.

2014

ClinicalTrials.gov Identifier: NCT01674647

PubMed.gov Identifier: 25182247

         

Return to top

Current Research

APPRAISE ATP

Patients with a Boston Scientific implantable cardioverter defibrillator (ICD) with decreased cardiac function are eligible to be randomized to 2 different ICD settings.

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov Identifier: NCT02923726

 

ARTESiA

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).

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov Identifier: NCT01938248

 

ATLAS S-ICD

Patients requiring a single chamber ICD are eligible to be randomized to 2 different types of ICD: transvenous versus subcutaneous.

Enrollment and follow-up of study participants concluded in January 2022; results are currently pending.

ClinicalTrials.gov Identifier: NCT02881255

 

AWARE

Patients with a history of episodic (paroxysmal) atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.

Enrollment and follow-up of study participants concluded in October 2021; study results are pending.

ClinicalTrials.gov Identifier: NCT02150902

 

CAPLA

Patients with a history of persistent atrial fibrillation who are undergoing ablation are eligible to be randomized to 2 different methods of ablation.

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ANZCTR.org.au Identifier: ACTRN12616001436460

 

CATCH-AF

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).

ClinicalTrials.gov Identifier: NCT04302311

 

COAST-AF

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.

ClinicalTrials.gov Identifier: NCT03347227

 

DREAM-SICD

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.

Chart review has concluded for this study; publication is currently pending.

Canadian Journal of Cardiology Publication

 

EARLY-AF

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.

Enrollment and follow-up of study participants concluded in March 2022; overall study results are pending.

ClinicalTrials.gov Identifier: NCT02825979

Interim Results: New England Journal of Medicine

 

HiRO Registry

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.  Participants are eligible to complete Biobanking.  This registry includes patients formerly enrolled in CASPERLQT, and ARVC.

ClinicalTrials.gov Identifier: NCT04189822

 

NODE-301 – RAPID

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

ClinicalTrials.gov Identifier: NCT03464019

 

NODE-303

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

ClinicalTrials.gov Identifier: NCT04072835

 

NODE-X

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.  This is a Phase 3 open label extension study of an Investigational Product (etripamil).

ClinicalTrials.gov Identifier: NCT04952610

Health Canada Identifier: Control Number 247598

 

OCEAN

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).

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov Identifier: NCT02168829

 

RAFT-AF

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.

Enrollment and follow-up of study participants concluded in January 2020.

ClinicalTrials.gov Identifier: NCT01420393

American College of Cardiology

Circulation Results 

 

RAFT-PermAF

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).

ClinicalTrials.gov Identifier: NCT01994252

 

REFINE-ICD

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.  Participants who are found to have these risk factors are eligible to be randomized to risk reduction with medication versus insertion of an ICD.  Participants without these risk factors are followed in a registry.

ClinicalTrials.gov Identifier: NCT00673842

 

RPM-CIED: ICD

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).  Patients in the remote monitoring arm use the VIRTUES platform, developed by CANet, to view information about their device reports.

ClinicalTrials.gov Identifier: NCT03405740

CANet information

VIRTUES information

 

STAR-AF 3

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.

ClinicalTrials.gov Identifier: NCT04428944

 

SyncAV

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.

ClinicalTrials.gov Identifier: NCT04100148

 

VANISH 2

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.

Enrollment has concluded for this study; follow-up of currently-enrolled patients is ongoing.

ClinicalTrials.gov Identifier: NCT02830360

 

Return to top

Completed Research
Project Name Sponsor Summary Year Project Closed For More Information…
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction Wyeth Research (now an owned subsidiary of Pfizer)

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.

Results: The study was terminated early due to lack of drug efficacy.

2006 ClinicalTrials.gov Identifier NCT00137332
ACT ICardiome Pharma Corp (now Advanz Pharma)  

This study was conducted to demonstrate the effectiveness of investigational drug RSD1235 (vernakalant) in the conversion of atrial fibrillation to sinus rhythm.

Results: Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.

2004 ClinicalTrials.gov Identifier NCT00468767
PubMed.gov Identifier 18332267
ACT V Astellas Pharma Canada (now Advanz Pharma)

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.

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

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.

2010

ClinicalTrials.gov Identifier NCT00989001

PubMed.gov Identifier 27233239

ACTIVE A Sanofi

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.

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.

2009

ClinicalTrials.gov Identifier NCT00249873

PubMed.gov Identifier 19336502

ACTIVE I Sanofi

 The 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.

Results: Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation.

2009

ClinicalTrials.gov Identifier NCT00249795

PubMed.gov Identifier 21388310

ADAPTIVE CRT (aCRT) Medtronic Cardiac Rhythm and Heart Failure

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.

Results: Higher percent synchronized Left Ventricular Pacing (sLVP)  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).

2012

ClinicalTrials.gov Identifier NCT00980057

PubMed.gov Identifier 23851059

ADONIS Sanofi

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.

Results: Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.

2003

ClinicalTrials.gov Identifier NCT00259376

PubMed.gov Identifier 17804843

ADVICE Montreal Heart Institute

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.

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.

2013

ClinicalTrials.gov Identifier NCT01058980

PubMed.gov Identifier 26211828

AF-CHF Montreal Heart Institute

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.

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.

2007

ClinicalTrials.gov Identifier NCT00597077

PubMed.gov Identifier 18565859

ALPHEE Sanofi

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.

Results: Celivarone was not effective for the prevention of ICD interventions or sudden death.

2011

ClinicalTrials.gov Identifier NCT00993382

PubMed.gov Identifier 22082672

AMADEUS Sanofi

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.

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.

2006

ClinicalTrials.gov Identifier NCT00070655

PubMed.gov Identifier 18294998

Amiodarone Aqueous I.V. Injection – Protocol # 0585K1-312-CA Wyeth-Ayerst Research and Wyeth-Ayerst Canada Inc.

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

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.

2002 Wyeth-Ayerst
ARISTOTLE Bristol-Myers Squibb

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.

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.

2011

ClinicalTrials.gov Identifier NCT00412984

PubMed.gov Identifier 21870978

ASPECT AT500 Medtronic

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

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.

2003 PubMed.gov Identifier 14678133
ASSERT St Jude Medical

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.

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.

2012 New England Journal of Medicine article
ASSERT-II Population Health Research Institute

The primary objective of the study was to determine the rate of detection of sub-clinical atrial fibrillation (≥ 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.

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.

2016

ClinicalTrials.gov Identifier NCT01694394

PubMed.gov Identifier 28778946

ATHENA Sanofi

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.

Results:  Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.

2008

ClinicalTrials.gov Identifier NCT00174785

PubMed.gov Identifier 19213680

BRUISE CONTROL Ottawa Heart Institute Research Corporation

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.

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.

2013

ClinicalTrials.gov Identifier NCT00800137

PubMed.gov Identifier 23659733

BRUISE CONTROL 2 Ottawa Heart Institute Research Corporation

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.

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.

2018

ClinicalTrials.gov Identifier NCT01675076

PubMed.gov Identifier 30462279

CART-HF Guidant, Inc. (now part of Boston Scientific Corporation)

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).

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.

2007 PubMed.gov Identifier 17241313
CIRCA-DOSE University of British Columbia

Patients with paroxysmal AF were randomized to either radiofrequency ablation, cryoablation 2 min, or cryoablation 4 min for reduction in recurrent arrhythmias.

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.

2019

ClinicalTrials.gov Identifier NCT01913522

PubMed.gov Identifier 31630538

Heart Rhythm Journal article

CO1 Biosense Webster, Inc.

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® 3 or the NavX(TM) System.

Results: This study was terminated early due to enrollment challenges.

2010 ClinicalTrials.gov Identifier NCT01036724
CONTAK CD and TR: Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure Guidant, Inc. (now part of Boston Scientific Corporation)

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.

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.

2002

ClinicalTrials.gov Identifier NCT00180258

PubMed.gov Identifier 15152059

CORONA: Models 4074/4574
Transvenous Steroid Eluting Pacing Leads Study
Medtronic Inc.

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.

Results: Model 4074 ventricular lead and Model 4574 atrial lead were approved for use.

2001

Medtronic Lead 4074

Medtronic Lead 4574

CORYFEE Sanofi

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.

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.

2006

ClinicalTrials.gov Identifier NCT00232310

PubMed.gov Identifier 22171925

CREDIT Guidant, Inc. (now part of Boston Scientific Corporation)

Canadian Registry of ICD Implant Testing Procedures.  The purpose of this registry was to document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Results: Defibrillation testing was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.

2008 ClinicalTrials.gov Identifier NCT00848341

Journal of Cardiovascular Electrophysiology article
CREDO Abbott Canada

Canadian Registry of Cardiac Implantable Electronic Device Outcomes.  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.

Results: The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low.  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.  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.

2019 CJC Open article
CTAF-2 Montreal Heart Institute

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.

Results: Perindopril does not reduce recurrence or the number of AF episodes in patients with hypertension and AF.

2015

ClinicalTrials.gov Identifier NCT00461903

CJC Open article

DEFEAT-HF Medtronic Cardiac Rhythm and Heart Failure

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

Results: The present study does not provide evidence to support a meaningful change in clinical outcomes for HF patients receiving SCS.

2015

ClinicalTrials.gov Identifier NCT01112579

PubMed.gov Identifier 26682789

DINAMIT St Jude Medical (now Abbott Medical Devices)

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.

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.

2004

New England Journal of Medicine article

PubMed.gov Identifier 15590950

DISCERN AF Ottawa Heart Institute Research Corporation

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.  This study sought to confirm whether patients’ symptoms or lack of symptoms post-ablation correlate well with actual episodes of AF.

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

2014

ClinicalTrials.gov Identifier NCT00745706

PubMed.gov Identifier 23266597

DUO-FLAIR St Jude Medical Inc (now Abbott Medical Devices)

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

Results: Cool Path Duo™ irrigated tip catheter is safe and effective in treating typical atrial flutter.  When compared to a six-hole irrigated tip catheter, the Cool Path Duo catheter delivers more power at a lower temperature.

2013 Journal of Interventional Cardiac Electrophysiology article
ELECTION Guidant Corporation (now part of Boston Scientific Corporation)

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

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.

2008

ClinicalTrials.gov Identifier NCT00848653

PubMed.gov Identifier 21273196

ELECTRA Sanofi

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.

Results: There is no difference in the AF recurrence rates and other variables between the patients starting dronedarone before cardioversion or after cardioversion.

2011

ClinicalTrials.gov Identifier NCT01026090

Sanofi

EMPIRIC Medtronic Inc.

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.

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.  Simplified and pre-specified ICD programming is possible without an increase in shock-related morbidity.

2004

Journal of the American College of Cardiology article

FDA News article

Current Controlled Trials in Cardiovascular Medicine article

EnRhythm MRI Medtronic Cardiac Rhythm and Heart Failure

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™ SureScan™ Pacing System by Medtronic (used in support of Revo MRI™ SureScan Pacing System launch).

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.

2010

ClinicalTrials.gov Identifier NCT00433654

PubMed.gov Identifier 19055703

FLEXION-AFL St Jude Medical Inc (now Abbott Medical Devices)

The purpose of this trial was to demonstrate that ablation with the St Jude Therapy™ Cool Flex™ 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.

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.  As a result, this system was approved for use by the FDA.

2012

ClinicalTrials.gov Identifier NCT01408485

FDA Approval information

Fortify™/Unify™ New Technology Assessment (NTA) St Jude Medical International, Inc (now Abbott Medical Devices)

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

Results: These devices are now approved for use.

2010 Biospace article
GEM III Medtronic Inc.

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.

Results: The GEM III DR ICD was approved for use.

2000 Med Device Online article
GLORIA-AF Registry Boehringer Ingelheim

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.  Anticoagulation use was observed and compared.

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.

2020

ClinicalTrials.gov Identifier NCT01468701

Boehringer Ingelheim

ICI COOL PATH Irvine Biomedical, Inc. (a St Jude Medical company)

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.  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.

Results: The  IBI Therapy Cool Path Ablation Catheter was approved for use for treatment of Atrial Flutter in 2007.

2007 FDA Report P060019
ICY AVNRT Medtronic Cardiac Rhythm and Heart Failure

The purpose of this study was to determine if the Medtronic Freezor® Xtra Surgical Cardiac CryoAblation catheter (“cryoablation catheter”) is safe and effective for the treatment of a kind of cardiac arrhythmia (atrioventricular nodal reentrant tachycardia – AVNRT).

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.

2016

ClinicalTrials.gov Identifier NCT01426425

PubMed.gov Identifier 29044787

LEAD LIFE Guidant Corporation (now part of Boston Scientific Corporation) 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.Results: The LEAD LIFE study demonstrated that the leads were safe and reliable over time.  Characterization of implant location, lead selection, and defibrillation testing were consistent across all sites.  There were minimal complications and observations in the study.
2004 ClinicalTrials.gov Identifier NCT00848835
LEARN Medtronic Cardiac Rhythm and Heart Failure

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.  The Medtronic Concerto CRT-ICD device was used in this study.

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.

 

ClinicalTrials.gov Identifier NCT01089634

PubMed.gov Identifier 17897121

Long term outcomes following pacemaker implantation and atrioventricular node ablation for management of atrial fibrillation
VCAT – Academic

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.

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.

2018 Published in Heart Lung and Circulation
MAIA Sanofi

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).

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.

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.

2006

ClinicalTrials.gov Identifier NCT00233441

PubMed.gov Identifier 22171925

MATRIX Biotronik SE & Co. KG

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.

Results: Pending

2020 ClinicalTrials.gov Identifier NCT01774357
MODEL 4195 Left Ventricular Lead Medtronic Cardiac Rhythm and Heart Failure

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.

Results: This lead was approved for release to US markets in 2008.

2006

ClinicalTrials.gov Identifier NCT00269230

Medtronic Lead 4195 Attain StarFix

MODEL 6949 Medtronic, Inc.

The purpose of this registry was to assess the handling and performance of the new Model 6949 lead from Medtronic, Inc (Sprint Fidelis).  This lead was used in connection with an ICD system used to control a dangerously fast-beating heart.  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.

Results: The Model 6469 Sprint Fidelis lead was approved for use.  Since this time, there has been an advisory on this lead, though it was not recommended to prophylactically replace the lead.

2004

Medtronic Lead 6949 Sprint Fidelis

Government of Canada Recall Notice

MVP TRIAL Medtronic Cardiac Rhythm and Heart Failure

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.  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.

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).  Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated.

2009

ClinicalTrials.gov Identifier NCT00281099

PubMed.gov Identifier 20685401

NODE 302 Milestone Pharmaceuticals Inc

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.

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.

2020 ClinicalTrials.gov Identifier NCT03635996
OPTIC St Jude Medical (now Abbott Medical Devices)

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.  The 3 medication regimes were: 1- amiodarone plus a beta blocker, 2- a beta blocker alone, and 3- sotalol.  The objective was to determine whether amiodarone plus a beta blocker or sotalol were superior to beta blocker alone.

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.

2004

ClinicalTrials.gov Identifier NCT00257959

PubMed.gov Identifier 16403928

PainFree SST Medtronic, Inc.

Phase 2 of the Safety and Clinical Performance of the Protect ICD and CRT-D study (Phase I: PROTECTA).   The purpose of the PainFree SmartShock Technology (SST) study was to evaluate the impact of the new SST features in reducing inappropriate ICD shocks.  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.

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.

2014

ClinicalTrials.gov Identifier NCT00982397

PubMed.gov Identifier 25637563

PubMed.gov Identifier 26988379

PALLAS Sanofi-Aventis

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.  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.

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

2012

ClinicalTrials.gov Identifier NCT01151137

PubMed.gov Identifier 22082198

POST 4 University of Calgary

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.

Results: Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden.

2020

ClinicalTrials.gov Identifier NCT01456481

Annals of Internal Medicine article

 

 

 

 

 

 

Return to top