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| Sponsor: | Population Health Research Institute |
|---|---|
| Collaborator: |
Johnson & Johnson |
| Information provided by: | Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00392054 |
Purpose
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Procedure: Pulmonary Vein Isolation performed by Catheter Ablation Drug: Conventional Antiarrhythmic Drug Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial |
Ablation arm cluster: death, cardiac tamponade, severe PV stenosis>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation.
Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation > 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation.
| Enrollment: | 127 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Catheter Ablation
Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation
|
Procedure: Pulmonary Vein Isolation performed by Catheter Ablation
Ablation will be done to achieve entrance block into all pulmonary veins.
|
|
Active Comparator: Antiarrhythmic Drug Therapy
Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
|
Drug: Conventional Antiarrhythmic Drug Therapy
Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF
|
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is estimated to affect 2.2 million people in the United States. AF is a major cause of stroke, adversely affects quality of life, and is associated with increased mortality. Despite advances in antiarrhythmic drug therapy, AF continues to be associated with significant morbidity. Although antiarrhythmic drug therapy is currently considered a first-line option, recent data indicate that more than 35% of Patients will have recurrence of AF despite best antiarrhythmic drug (AAD) therapy, and more than 30% of Patients will discontinue the drugs because of adverse reactions. Furthermore, although recent trials have indicated equivalence of rhythm and rate control strategies in some patient populations, 25-35% of Patients with AF who are rate controlled will continue to have activity limiting symptoms. Newer measures to prevent, treat and potentially cure AF are needed. Seminal work by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic foci found primarily in the pulmonary veins (PV). Experience with the catheter-based Maze technique led to observations that opened the door to effective and practical catheter-based cures for AF. In response to the difficulties of focal ablation, an alternate strategy has been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue. Empirical PV isolation targets all of the PV's without regard to the initiation of ectopic beats. The goal is to create entrance block in the PV. Multipolar circular catheters and basket catheters have been developed that facilitate identification of the electrical connections that are present at the junction of the atrium and the PV, and radiofrequency energy is applied in a circumferential fashion until entrance block is achieved. Relative to focal ablation, circumferential PV isolation is simpler to perform, can be completed without inducing AF, has a shorter procedure time, and has a lower incidence of PV stenosis.
Comparison: Patients will have ablation to achieve entrance and/or exit block into all pulmonary veins, compared with patients receiving antiarrhythmic drugs given in accordance with ACC/AHA/ESC 2006 Guidelines for the Management of patients with AF.
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Texas Cardiac Arrhythmia Foundation | |
| Austin, Texas, United States, 78705 | |
| Austin Heart | |
| Austin, Texas, United States, 78756 | |
| Canada, British Columbia | |
| Victoria Cardiac Arrhythmia Trials Inc. | |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| London Health Sciences Centre University Hospital | |
| London, Ontario, Canada, N6A 5A5 | |
| Southlake Regional Health Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| McGill University | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Canada | |
| Institut Universitaire de Cardiologie et Pneumologie de Québec | |
| Quebec, Canada, G1V 4G5 | |
| Czech Republic | |
| Institute for Clinical and Experimental Medicine | |
| Prague, Prague 4, Czech Republic | |
| Charles University | |
| Prague, Czech Republic | |
| Germany | |
| Abteilung Rhythmologie | |
| Bad Krozingen, Germany, 79188 | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany, 79188 | |
| University Hospital Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Italy | |
| F. Miulli Hospital | |
| Acquaviva delle Fonti, Bari, Italy, 70021 | |
| Principal Investigator: | Carlos A Morillo, MD | Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University |
| Principal Investigator: | Natale Andrea, MD | Texas Cardiac Arrhythmia Research Foundation |
More Information
| Responsible Party: | Dr. Andrea Natale, unaffiliated IDE study sponsor, Texas Cardiac Arrhythmia Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00392054 History of Changes |
| Other Study ID Numbers: | USJan13/09CANAug1/06EUJan1/07 |
| Study First Received: | October 23, 2006 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada European Union: European Medicines Agency |
|
Atrial Fibrillation Paroxysmal Pulmonary Vein Isolation |
Ablation Catheter Anti-arrhythmic Drug Therapy First Line Therapy |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |