Key result
Sacubitril/valsartan will be evaluated for its efficacy on sinus rhythm maintenance over 12 months in a planned randomized controlled trial of 462 patients with persistent atrial fibrillation after catheter ablation.
Why the study?
Recurrence rates after catheter ablation for persistent atrial fibrillation are high, and few studies have evaluated whether sacubitril/valsartan reduces recurrence or improves cardiovascular outcomes in these patients.
Does sacubitril/valsartan improve sinus rhythm maintenance in adult patients with persistent atrial fibrillation without reduced ejection fraction heart failure after catheter ablation?
RCT (n=462)
Open-label
Dynamic stratified block group randomization
Yes
Does sacubitril/valsartan improve sinus rhythm maintenance in adult patients with persistent atrial fibrillation without reduced ejection fraction heart failure after catheter ablation?
This study protocol outlines a randomized controlled trial to evaluate whether adding sacubitril/valsartan to standard therapy improves sinus rhythm maintenance after catheter ablation in patients with persistent atrial fibrillation and preserved ejection fraction.
Tests sacubitril/valsartan for post-ablation rhythm maintenance in persistent AF with preserved EF; RCT will extend ARNI evidence beyond HFrEF.
Introduction: A high recurrence rate of atrial fibrillation was monitored after catheter ablation for persistent atrial fibrillation. Sacubitril/valsartan can improve outcomes for patients with heart failure and ventricular tachycardia, but few studies examined whether it can reduce recurrence or improve cardiovascular outcomes in patients with persistent atrial fibrillation after catheter ablation. In this study, we will assess the effect of sacubitril/valsartan on sinus rhythm maintenance and incidence of major adverse cardiovascular events (MACE) in patients with persistent atrial fibrillation after catheter ablation through a randomized controlled trial (RCT). Methods: This is a multi-center, randomized, controlled, open-label, superiority clinical trial involving 462 patients without reduced ejection fraction heart failure after catheter ablation of persistent atrial fibrillation. Patients will be randomized to (1) receive the standard treatment strategy plus sacubitril/valsartan titration, or (2) receive the standard treatment strategy without taking sacubitril/valsartan. The primary outcome will be sinus rhythm maintenance rate over 12 months, monitored by random electrocardiogram and 24-h Holter electrocardiogram. Discussion: This study is designed to evaluate the effect of sacubitril/valsartan on sinus rhythm maintenance and incidence of major adverse cardiovascular events (MACE) in patients with persistent atrial fibrillation after catheter ablation. The results will evaluate sacubitril/valsartan as a novel treatment for improving prognosis and a complement to conventional drug therapy. Trial Registration: Registered with Chinese Clinical Trials Registry on 27 August 2022, identifier: ChiCTR2200062995.
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Qiu et al. (2024) conducted an RCT in Persistent atrial fibrillation without reduced ejection fraction heart failure (n=462). Sacubitril/valsartan vs. Standard treatment strategy without sacubitril/valsartan was evaluated on Sinus rhythm maintenance rate over 12 months. Sacubitril/valsartan will be evaluated for its efficacy on sinus rhythm maintenance over 12 months in a planned randomized controlled trial of 462 patients with persistent atrial fibrillation after catheter ablation.
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