Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial.

Abstract

Atrial fibrillation (AF) is common in patients with rheumatic mitral valve disease (RMVD) and increase the risk of stroke and death. Bi-atrial or left atrial ablation remains controversial for treatment of AF during mitral valve surgery. The study aims to compare the efficacy and safety of bi-atrial ablation with those of left atrial ablation among patients with RMVD and persistent or long-standing persistent AF. The ABLATION trial (Bi-atrial vs Left Atrial Ablation for Patients with RMVD and Non-paroxysmal AF) is a prospective, multicentre, randomised controlled study. The trial will randomly assign 320 patients with RMVD and persistent or long-standing persistent AF to bi-atrial ablation procedure or left atrial ablation procedure in a 1:1 randomisation. The primary end point is freedom from documented AF, atrial flutter or atrial tachycardia of >30 s at 12 months after surgery off antiarrhythmic drugs. Key secondary end point is the probability of freedom from permanent pacemaker implantation at 12 months after surgery. Secondary outcomes include the probability of freedom from any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs, AF burden, incidence of adverse events and cardiac function documented by echocardiography at 12 months after operation. The central ethics committee at Fuwai Hospital approved the ABLATION trial. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations. NCT05021601.