First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study) (RAAFT)
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|ClinicalTrials.gov Identifier: NCT00392054|
Recruitment Status : Unknown
Verified July 2011 by Population Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : October 25, 2006
Last Update Posted : July 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Pulmonary Vein Isolation performed by Catheter Ablation Drug: Conventional Antiarrhythmic Drug Therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2012|
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
- Time to first episode of symptomatic atrial fibrillation [ Time Frame: Assessed during 21 month follow-up period ]Time to first recurrence of electrocardiographically documented symptomatic atrial fibrillation lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization.
- Comparison of proportion of patients with an occurrence of any of a cluster of serious complications in either arm [ Time Frame: Assessed during entire 24 month study period ]
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.
- 1. Total of symptomatic and asymptomatic AF episodes documented by TTM [ Time Frame: During 21 month follow-up period ]Patients are assigned a transtelephonic monitoring devide throughout the duration of follow-up and record ECGs whenever experiencing symptoms of AF plus one regular bi-weekly asymptomatic recording. The total of all recorded episodes of atrial fibrillation will be compared.
- 2. Quality of life at 1-year follow-up (EQ-5D). [ Time Frame: Measured at baseline, 6 months and 12 months after randomization ]The standard EQ-5D questionnaire is completed by study participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392054
|United States, Texas|
|Texas Cardiac Arrhythmia Foundation|
|Austin, Texas, United States, 78705|
|Austin, Texas, United States, 78756|
|Canada, British Columbia|
|Victoria Cardiac Arrhythmia Trials Inc.|
|Victoria, British Columbia, Canada, V8R 4R2|
|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|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Montreal, Quebec, Canada, H3G 1A4|
|Institut Universitaire de Cardiologie et Pneumologie de Québec|
|Quebec, Canada, G1V 4G5|
|Institute for Clinical and Experimental Medicine|
|Prague, Prague 4, Czech Republic|
|Prague, Czech Republic|
|Bad Krozingen, Germany, 79188|
|Asklepios Klinik St. Georg|
|Hamburg, Germany, 79188|
|University Hospital Eppendorf|
|Hamburg, Germany, D-20246|
|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|