Cryoballoon Ablation of Pulmonary Veins for Persistent Atrial Fibrillation: Results From the Multicenter STOP Persistent AF Trial.

Abstract Background Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF). Objectives To assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF. Methods STOP Persistent AF (NCT03012841) was a prospective, multicenter, single-arm, FDA-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes 40% and Results Of 186 total enrollments, 165 subjects (70% male, 65±9 years, left atrial diameter 4.2±0.6 cm, body mass index 31±6) were treated at 25 sites in the United States, Canada, and Japan. Total procedure, left atrial dwell, and fluoroscopy times were 121±46, 102±41, and 19±16 min, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% CI: 46.7%-62.1%) freedom from AF, AFL or AT. There was one primary safety event, translating to a rate of 0.6% (95% CI: 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P Conclusions The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes