Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation (CASTLE-AF) - study design.

BACKGROUND Electrical isolation of the pulmonary veins by catheter ablation is an emerging treatment modality for the treatment of atrial fibrillation (AF) and is increasingly used in patients with heart failure. METHODS The catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation trial (CASTLE-AF) is a randomized evaluation of ablative treatment of atrial fibrillation in patients with left ventricular dysfunction. The primary endpoint is the composite of all-cause mortality or worsening of heart failure requiring unplanned hospitalization using a time to first event analysis. Secondary endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of heart failure requiring unplanned hospitalization, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, quality of life, number of therapies (shock and antitachycardia pacing) delivered by the implantable cardioverter-defibrillator (ICD), time to first ICD therapy, number of device-detected ventricular tachycardia and ventricular fibrillation episodes, AF burden, AF free interval, left ventricular function, exercise tolerance, and percentage of right ventricular pacing. CASTLE-AF will randomize 420 patients for a minimum of 3 years at 48 sites in the United States, Europe, Australia, and South America.