Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

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.

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