A clinical and health-economic evaluation of pulmonary vein encircling ablation compared with antiarrhythmic drug treatment in patients with persistent atrial fibrillation (Catheter Ablation for the Cure of Atrial Fibrillation-2 study)

AIMS: Catheter Ablation for the Cure of Atrial Fibrillation 2 study is a prospective, randomized trial aimed to demonstrate the efficacy of catheter ablation with combined lesions in the right and left atria, in preventing atrial fibrillation (AF) recurrences among patients with recurrent persistent AF refractory to one antiarrhythmic drug, in comparison with the best pharmacological therapy. METHODS AND RESULTS: Enrolment is limited to patients aged between 18 and 70 years who have experienced at least one documented relapse of persistent AF during antiarrhythmic drug therapy. One hundred and twenty-six patients will be randomized to ablation or antiarrhythmic drug therapy in a 2 : 1 manner. In the ablation group, the patients will undergo right and left atrial linear ablation. Control group patients will be treated with the best antiarrhythmic drug. After an initial blanking period of 2 months patients will be followed for 24 months. Primary endpoint of the study is the absence of documented persistent atrial tachyarrhythmias relapse during the first 24 months after the blanking period. Enrolment is scheduled in 14 centres in Italy, UK, Austria, and Finland. Seventy-two patients have currently been enrolled. CONCLUSION: This study will provide important data about the efficacy of catheter ablation in comparison with antiarrhythmic drugs for the treatment of persistent AF.