ArticleBMJ open2022
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.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05021601 (Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
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6 authors at 1 institution in 1 country.
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Abstract
introductionAtrial 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05021601.
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