Brugada Syndrome Ablation for the Prevention of Ventricular Fibrillation Episodes (BRAVE)

Abstract

Background: Catheter ablation has emerged as a promising treatment to prevent ventricular fibrillation (VF) in Brugada syndrome (BrS). However, evidence from a prospective, randomized clinical trial is lacking. Objective: The Brugada Syndrome Ablation for the Prevention of Ventricular Fibrillation Episodes trial is a prospective, multicenter, 2-arm, randomized (1:1), open-label clinical study designed to evaluate the efficacy and safety of ablation therapy in patients with symptomatic BrS. Methods: We enrolled patients with symptomatic BrS with an implantable cardioverter-defibrillator. Patients were randomized to ablation therapy or control groups. Ablation targeted arrhythmogenic areas identified through electroanatomical mapping, predominantly at the right ventricular epicardium. The primary outcome was the first occurrence of VF or death. One interim analysis was planned after 50 patients were randomized. Results: Of 67 patients screened, 52 were randomized (25 to ablation, 25 to control, 2 withdrawals), and 15 declined randomizations but remained in a registry (10 chose ablation, 5 opted against ablation). After 3 years of follow-up, the ablation group had significantly fewer VF events than the control group (hazard ratio, 0.288; P = .0184). At the interim analysis, the Data Safety Monitoring Board recommended early trial termination. Among all ablation recipients (including crossovers and registry participants), 83% remained VF free after a single procedure and 90% after a repeat ablation. Complications of ablation included 1 hemopericardium without a long-term sequel. Conclusion: Epicardial substrate ablation significantly reduces VF recurrence in patients with symptomatic BrS with implantable cardioverter-defibrillators and seems safe, supporting its potential role as a first-line therapy to prevent recurrent VF in patients with symptomatic BrS.