Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Abbott Medical Devices; Duke Clinical Research Institute; St. Jude Medical
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Calcium Channel Blockers

Criteria

Inclusion Criteria:

• Have documented AF, which warrants active drug or ablative treatment

• Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs

• Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography

Exclusion Criteria:

• Previously failed 2 or more membrane active anti-arrhythmic drugs

• Efficacy failure of a full dose Amiodarone trial of >12 weeks duration

• Any amiodarone therapy in the past three months

• Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma

• Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age

• Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months

• Hypertrophic obstructive cardiomyopathy

• Class IV angina or congestive heart failure

• Planned heart transplantation

• Other mandated anti-arrhythmic drug therapy

• Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs

• Prior left atrial catheter ablation with the intention to treat AF

• Patients with other arrhythmias requiring ablative therapy

• Prior surgical interventions for AF such as the MAZE procedure

• Prior atrioventricular nodal ablation

• Medical conditions limiting expected survival to <1 year

• Contraindication to warfarin anti-coagulation

• Women of childbearing potential

• Participation in any other clinical mortality trial

• Unable to give informed consent