Nery Pablo B, Wells George A, Verma Atul, Joza Jacqueline, Nair Girish M, Veenhuyzen George, Andrade Jason, Nault Isabelle, Wong Jorge A, Sikkel Markus, Essebag Vidal, Macle Laurent, Sapp John, Roux Jean-Francois, Skanes Allan, Angaran Paul, Novak Paul, Redfearn Damian, Golian Mehrdad, Redpath Calum J, Sturmer Marcio, Birnie David
Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Canada..
Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Canada.; Cardiovascular Research Methods Center, University of Ottawa Heart Institute, Ottawa, Canada.
Am Heart J. 2022 Dec;254:133-140. doi: 10.1016/j.ahj.2022.08.010. Epub 2022 Aug 27.
Atrial low voltage area (LVA) catheter ablation has emerged as a promising strategy for ablation of persistent atrial fibrillation (AF). It is unclear if catheter ablation of atrial LVA increases treatment success rates in patients with persistent AF.
The primary aim of this trial is to assess the potential benefit of adjunctive catheter ablation of atrial LVA in addition to pulmonary vein isolation (PVI) in patients with persistent AF, when compared to PVI alone. The secondary aims are to evaluate safety outcomes, the quality of life and the healthcare resource utilization.
METHODS/DESIGN: A multicenter, prospective, parallel-group, 2-arm, single-blinded randomized controlled trial is under way (NCT03347227). Patients who are candidates for catheter ablation for persistent AF will be randomly assigned (1:1) to either PVI alone or PVI + atrial LVA ablation. The primary outcome is 18-month documented event rate of atrial arrhythmia (AF, atrial tachycardia or atrial flutter) post catheter ablation. Secondary outcomes include procedure-related complications, freedom from atrial arrhythmia at 12 months, AF burden, need for emergency department visits/hospitalization, need for repeat ablation for atrial arrhythmia, quality of life at 12 and 18 months, ablation time, and procedure duration.
Characterization of Arrhythmia Mechanism to Ablate Atrial Fibrillation (COAST-AF) is a multicenter randomized trial evaluating ablation strategies for catheter ablation. We hypothesize that catheter ablation of atrial LVA in addition to PVI will result in higher procedural success rates when compared to PVI alone in patients with persistent AF.
心房低电压区（LVA）导管消融已成为一种有前景的持续性心房颤动（AF）消融策略。目前尚不清楚心房LVA导管消融是否能提高持续性AF患者的治疗成功率。
本试验的主要目的是评估在持续性AF患者中，与单纯肺静脉隔离（PVI）相比，在PVI基础上联用心房LVA导管消融的潜在益处。次要目的是评估安全性结局、生活质量和医疗资源利用情况。
方法/设计：一项多中心、前瞻性、平行组、双臂、单盲随机对照试验正在进行中（NCT03347227）。适合进行持续性AF导管消融的患者将被随机分配（1:1）至单纯PVI组或PVI + 心房LVA消融组。主要结局是导管消融术后18个月记录到的房性心律失常（AF、房性心动过速或心房扑动）事件发生率。次要结局包括与手术相关的并发症、12个月时无房性心律失常、AF负荷、急诊就诊/住院需求、因房性心律失常需要再次消融、12个月和18个月时的生活质量、消融时间和手术持续时间。
心律失常机制消融房颤的特征（COAST-AF）是一项评估导管消融策略的多中心随机试验。我们假设，在持续性AF患者中，与单纯PVI相比，PVI基础上联用心房LVA导管消融将带来更高的手术成功率。
