Protocol for a prospective, multicenter, randomized, controlled trial comparing pulsed field ablation vs. cryoballoon ablation in patients with persistent atrial fibrillation (PEACE trial)

Background: Catheter ablation has become a standard treatment for atrial fibrillation (AF). However, evidence regarding the efficacy and safety of pulsed field ablation (PFA) in patients with persistent AF (PeAF) remains limited. The PEACE trial aims to evaluate the efficacy and safety of PFA compared to cryoballoon ablation (CBA) in PeAF. Methods: This prospective, multicenter, open-label, randomized controlled, non-inferiority trial (NCT07064616, UMIN000057896) will enroll 300 patients with PeAF, randomly assigned (1:1) to undergo either PFA using the PulseSelect™ or cryoballoon ablation (CBA) using the Arctic Front Advance™. The primary efficacy endpoint is atrial tachyarrhythmia recurrence within 12 months. The primary safety endpoint is procedure-related complications within 30 days. Secondary outcomes include early recurrence, changes in LA diameter, natriuretic peptide levels, and patient-reported symptoms. Expected results: We hypothesize that PFA will be non-inferior to CBA in terms of efficacy and safety. Conclusions: The PEACE trial will provide essential data regarding the efficacy and safety of PFA compared to CBA in patients with PeAF, potentially informing future clinical practice.