Selective complex fractionated atrial electrograms targeting for atrial fibrillation study (SELECT AF): a multicenter, randomized trial

Abstract

BACKGROUND: This study compared generalized complex fractionated atrial electrograms (CFAE) ablation versus a selective CFAE ablation strategy targeting areas of continuous electric activity. METHODS AND RESULTS: Subjects with symptomatic, persistent/high-burden paroxysmal atrial fibrillation (AF) were enrolled at 6 centers (n=86) and randomized to 1 of 2 arms. For group I, all CFAE regions with an interval confidence level >7 were ablated followed by pulmonary vein isolation (PVI). For group II, only CFAE sites with continuous electric activity were ablated followed by PVI. For PVI, all 4 PV antra were isolated with confirmed entrance block. Subjects were followed for 1 year with a visit, ECG, and 48-hour Holter every 3 months. Symptoms were confirmed by loop recording. The primary end point was freedom from arrhythmia >30 seconds at 1 year. For both group I and II, CFAE ablation prolonged AF cycle length (25±33 versus 23±33 ms; P=0.78) and resulted in similar rates of AF termination (37% versus 28%; P=0.42). Radiofrequency duration during CFAE ablation was significantly less in group II (23±20 versus 38±20 minutes; P=0.002). At 1-year follow-up, freedom from AF/atrial flutter/atrial tachycardia recurrence was significantly higher in group I versus group II after 1 procedure (50% versus 28%; P=0.03). There were also significantly fewer repeat procedures in group I (13% versus 36%; P=0.021). CONCLUSIONS: Continuous electric activity ablation+PVI result in a similar incidence of acute AF termination with significantly less radiofrequency time. However, incidence of repeat procedures and long-term recurrence of AF/atrial flutter/atrial tachycardia are significantly lower using generalized CFAE ablation+PVI. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00926783.