First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study) (RAAFT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00392054|
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
|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|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 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
- Number of Participants With Recurrence of Atrial Tachyarrhythmia [ Time Frame: Assessed during 21 month follow-up period ]Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).
- 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.
- Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia [ Time Frame: 21 months of follow-up ]Including only symptomatic episodes of all atrial tachyarrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).
- Number of Participants With Recurrence of Symptomatic Atrial Fibrillation [ Time Frame: During 21 month follow-up period ]Including only symptomatic episodes of atrial fibrillation in the outcome measure (excluding asymptomatic events and events adjudicated as atrial flutter or atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).
- Episodes of ANY Recurrence of Atrial Tachyarrhythmia [ Time Frame: During 21 month follow-up period ]Including all episodes of symptomatic or asymptomatic atrial fibrillation, atrial flutter and atrial tachycardia. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).
- Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically [ Time Frame: During 21 month follow-up period ]Including only events documented by 12 lead ECG, Holter monitoring or rhythm strips but excluding TTM monitoring. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).
- Quality of Life EQ5D Index Score [ Time Frame: Measured at 12 months after randomization ]The standard EQ-5D questionnaire is completed by study participants. The EQ-5D Index score is a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Self-reported severity for each dimension is given on a 3 level scale: (1) no problems, (2) some problems or (3) major problems. For example a health state: 11223 means: no problems with mobility (1), no problems with self-care (1), some problems with performing usual activity (2), moderate pain/discomfort (2), and major anxiety/depression (3). Thus there are 243 patterns of health state: 11111 to 33333. Scores are converted to a single weighted index score (utility). The index score is derived by applying a formula as developed by Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005; 43(3): 203-220. The final score has a minimum value of 0 and maximum value of 1 (no problems).
- Quality of Life EQ-5D Visual Analog Score [ Time Frame: Measured At 12 months after randomization ]The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale measures how good/bad one's own health is today, in one's own opinion. 0 means the worst imaginable state of health; 100 means the best imaginable state of health.
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, Czechia|
|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|