A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF) (APAF2)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring symptomatic, paroxysmal, atrial fibrillation
Eligibility Criteria
Inclusion Criteria: Age 18-70 years History of symptomatic paroxysmal AF lasting more than 6 months. Paroxysms of AF are intended as recurrent self-terminating episodes lasting less than 7 days and occurring more than 2 times every month. Exclusion Criteria: Pregnancy NYHA functional class III or IV Left atrial size > 65 mm Left ventricular (LV) ejection fraction < 35% Contraindication to anticoagulation with warfarin History of myocardial infarction within six months of the procedure Prior catheter or surgical ablation attempt for AF Inability or unwillingness to provide written informed consent Life expectancy less than 1 year Significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance < 20 mL/h), severe chronic obstructive lung disease, cirrhosis, etc) Anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease. Presence of left atrial thrombus. Prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively AF burden < 2 episodes/month WPW Expected survival < 1 year Contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone not listed above: LV hypertrophy (LV mass index > 125g/m2) thyroid dysfunction (hyperthyroidism or uncontrolled hypothyroidism or thyroid cancer) liver dysfunction (ALT or AST >2x the reference values) Interstitial lung disease with DLCO<70% of predicted or severe asthma. QT interval exceeding 400 msec Symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker had been implanted Evidence of stress-induced myocardial ischemia
Sites / Locations
- San Raffaele University Hospital