Abstract Body (Do not enter title and authors here): Hypothesis and Purpose:
The primary hypothesis of the CRRF-PeAF study was that cryoballoon (CB) ablation is not inferior to radiofrequency (RF) ablation with respect to the clinical efficacy in patients with persistent atrial fibrillation (PeAF). The purpose of this study was to compare the efficacy and safety of catheter ablation (CA) between CB and RF ablation in patients with PeAF.
Methods:
Study Design
The CRRF-PeAF study is a prospective, multicenter, open-label, controlled, randomized, non-inferiority clinical trial comparing the efficacy and safety of AF ablation at 1-year with a blanking period (BP) of 90 days between CB and RF ablation in patients with PeAF.
Population Studied
Patients aged 20 - 85 years with PeAF were eligible for the study. We randomized 500 individuals across 11 centers in Japan between April 2021 and June 2023, allocating them in a 1-to-1 fashion to undergo either CB or RF ablation.
Interventions
Pulmonary vein isolation (PVI) was mandatory for all patients undergoing CA of AF. Adjunctive ablation lesion sets targeting sites outside the PVs were performed at the physician’s direction.
Follow-up
One-channel electrocardiograms were recorded twice daily for 1-year after CA, using an ambulatory electrogram recorder, in addition to other scheduled examinations, including 12-lead ECGs and 24-hour Holter recordings at 3- and 12-months after CA. All documented atrial tachyarrhythmias (ATs) lasting ≥ 30 seconds occurring outside the 90-day BP were considered recurrences.
The primary and Secondary End Points
The primary endpoint was the occurrence of ATs at 1-year with a 90-day BP after CA. The key secondary endpoints were as follows: success rate of PVI, total procedural time, LA (left atrial) dwelling time, complication rate, change in LA volume index, QoL, hospitalization for heart failure, and mortality.
Sample Size and Statistical analysis
A freedom rate at 1-year of 60% in both groups was assumed, and the non-inferiority hypothesis was evaluated using a log-rank test with a non-inferiority margin for a hazard ratio of 1.5. The sample size was calculated as 239 patients per group with a power of 80% based on a significance level of 2.5%. To account for potential loss to follow-up, 500 patients (250 patients per group) were enrolled.
Results:
The results of this study are currently under investigation.
Conclusion:
The CRRF-PeAF study is underway to compare the efficacy and safety of CA of AF between CB and RF ablation in patients with PeAF.