Clinical trial NCT00578617
Conditions: Atrial Fibrillation Arrhythmia
Keywords: Atrial fibrillation Left Atrial Ablation Pulmonary Vein Isolation Catheter Ablation Antiarrhythmic Drug Therapy
Sponsor: Mayo Clinic
Start date: 2006-09-01; Completion date: 2010-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.

Detailed description:
The need for this trial arises out of 1) the rapidly increasing number of pts \> 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

Arms: arm 1: Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug. arm 2: Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
Interventions: intervention 1: Rate Control intervention 2: Ablation Therapy intervention 3: Rate Control intervention 4: Rate control intervention 5: Rate control intervention 6: Rate control intervention 7: Rate Control intervention 8: Rate Control intervention 9: Rate Control intervention 10: Rhythm Control intervention 11: Rhythm control intervention 12: Rhythm control intervention 13: Rhythm control intervention 14: Rhythm control intervention 15: Rhythm control
Intervention descriptions: intervention 1: Metoprolol 50-100mg intervention 2: None intervention 3: Atenolol 50-100mg, intervention 4: Propranolol 40-80mg intervention 5: Acebutolol 200mg intervention 6: Carvedilol 6.25mg intervention 7: Diltiazem 180-240mg intervention 8: Verapamil 180-240mg intervention 9: Digoxin 0.125mg intervention 10: Propafenone 450mg intervention 11: Flecainide 200mg intervention 12: Sotalol 240mg intervention 13: Dofetilide 500mcg intervention 14: Amiodarone 200mg intervention 15: Quinidine 600-900mg

Protocol documents: