Efficacy of LGE‐MRI‐guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design

医学 心房颤动 导管消融 烧蚀 心脏病学 内科学 房性心动过速 心房扑动 肺静脉 临床终点 多中心试验 随机对照试验 危险系数 心包积液 前瞻性队列研究 置信区间 多中心研究
作者
Nassir F. Marrouche,Tom Greene,Anthony J. Dean,Eugene Kholmovski,Leonie Morrison‐de Boer,Moussa Mansour,Hugh Calkins,Francis E. Marchlinski,David J. Wilber,Gerhard Hindricks,Christian Mahnkopf,Pierre Jaı̈s,Prashanthan Sanders,Johannes Brachmann,J BAX,Lilas Dagher,Oussama M. Wazni,Nazem Akoum
出处
期刊:Journal of Cardiovascular Electrophysiology [Wiley]
卷期号:32 (4): 916-924 被引量:61
标识
DOI:10.1111/jce.14957
摘要

Success rates of catheter ablation in persistent atrial fibrillation (AF) remain suboptimal. A better and more targeted ablation strategy is urgently needed to optimize outcomes of AF treatment. We sought to assess the safety and efficacy of targeting atrial fibrosis during ablation of persistent AF patients in improving procedural outcomes.The DECAAF II trial (ClinicalTrials. gov identifier number NCT02529319) is a prospective, randomized, multicenter trial of patients with persistent AF. Patients with persistent AF undergoing a first-time ablation procedure were randomized in a 1:1 fashion to receive conventional pulmonary vein isolation (PVI) ablation (Group 1) or PVI + fibrosis-guided ablation (Group 2). Left atrial fibrosis and ablation induced scarring were defined by late gadolinium enhancement magnetic resonance imaging at baseline and at 3-12 months postablation, respectively. The primary endpoint is the recurrence of atrial arrhythmia postablation, including atrial fibrillation, atrial flutter, or atrial tachycardia after the 90-day postablation blanking period. Patients were followed for a period of 12-18 months with a smartphone ECG Device (ECG Check Device, Cardiac Designs Inc.). With an anticipated enrollment of 900 patients, this study has an 80% power to detect a 26% reduction in the hazard ratio of the primary endpoint.The DECAAF II trial is the first prospective, randomized, multicenter trial of patients with persistent AF using imaging defined atrial fibrosis as a treatment target. The trial will help define an optimal approach to catheter ablation of persistent AF, further our understanding of influencers of ablation lesion formation, and refine selection criteria for ablation based on atrial myopathy burden.

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