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The efficacy and safety of left atrial low-voltage area guided ablation for recurrence prevention compared to pulmonary vein isolation alone in patients with persistent atrial fibrillation trial: Design and rationale
Clinical Cardiology ( IF 2.4 ) Pub Date : 2021-07-22 , DOI: 10.1002/clc.23677
Akihiro Sunaga 1 , Masaharu Masuda 2 , Koichi Inoue 3, 4 , Nobuaki Tanaka 3 , Tetsuya Watanabe 5 , Yoshio Furukawa 5 , Yasuyuki Egami 6 , Akio Hirata 7 , Nobuhiko Makino 7 , Hitoshi Minamiguchi 1, 7 , Takafumi Oka 1, 3 , Tomoko Minamisaka 8 , Toshihiro Takeda 9 , Tomomi Yamada 10 , Tetsuhisa Kitamura 11 , Hirota Kida 1 , Bolrathanak Oeun 1 , Taiki Sato 1 , Yohei Sotomi 1 , Tomoharu Dohi 1 , Katsuki Okada 1 , Shinichiro Suna 1 , Hiroya Mizuno 1 , Daisaku Nakatani 1 , Shungo Hikoso 1 , Yasushi Sakata 1 ,
Affiliation  

Recurrence rates of atrial fibrillation (AF) after pulmonary vein isolation (PVI) are higher in patients with a left atrial low-voltage area (LVA) than those without. However, the efficacy of LVA guided ablation is still unknown. The purpose of this study—the Efficacy and Safety of Left Atrial Low-voltage Area Guided Ablation for Recurrence Prevention Compared to Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation trial (SUPPRESS-AF trial)—is to elucidate whether LVA guided ablation in addition to PVI is superior to PVI alone in patients with persistent AF. The Osaka Cardiovascular Conference will conduct a multicenter, randomized, open-label trial aiming to examine whether LVA guided ablation in addition to PVI is superior to PVI alone in patients with persistent AF and LVAs. The primary outcome is the recurrence of AF documented by scheduled or symptom-driven electrocardiography (ECG) during the 1 year follow-up period after the index ablation. The key secondary endpoints include all-cause death, symptomatic stroke, bleeding events, and other complications related to the procedure. A total of 340 patients with an LVA will be enrolled and followed up to 1 year. The SUPPRESS-AF trial is a randomized controlled trial designed to assess whether LVA guided ablation in addition to PVI is superior to PVI alone for patients with persistent AF and LVAs detected while undergoing their first catheter ablation.

中文翻译:

左心房低电压区域引导消融与单独肺静脉隔离在持续性房颤患者中预防复发的有效性和安全性试验:设计和基本原理

有左心房低电压区 (LVA) 的患者在肺静脉隔离 (PVI) 后房颤 (AF) 的复发率高于无左心房低电压区 (LVA) 的患者。然而,LVA 引导消融的疗效尚不清楚。本研究的目的——在持续性房颤试验(SUPPRESS-AF 试验)患者中左心房低电压区域引导消融预防复发的有效性和安全性与单独肺静脉隔离相比——是阐明 LVA 引导消融是否在对于持续性房颤患者,加用 PVI 优于单独使用 PVI。大阪心血管会议将进行一项多中心、随机、开放标签试验,旨在检查在持续性 AF 和 LVA 患者中,除了 PVI 外,LVA 引导消融是否优于单独 PVI。主要结果是在指数消融后的 1 年随访期间,由计划的或症状驱动的心电图 (ECG) 记录的 AF 复发。关键的次要终点包括全因死亡、有症状的中风、出血事件和其他与手术相关的并发症。总共 340 名 LVA 患者将入组并随访至 1 年。SUPPRESS-AF 试验是一项随机对照试验,旨在评估除 PVI 外 LVA 引导的消融是否优于单独 PVI,用于治疗持续性 AF 和在接受第一次导管消融时检测到 LVA 的患者。以及与手术相关的其他并发症。总共有 340 名 LVA 患者将入组并随访至 1 年。SUPPRESS-AF 试验是一项随机对照试验,旨在评估除 PVI 外 LVA 引导的消融是否优于单独 PVI,用于治疗持续性 AF 和在接受第一次导管消融时检测到 LVA 的患者。以及与手术相关的其他并发症。总共有 340 名 LVA 患者将入组并随访至 1 年。SUPPRESS-AF 试验是一项随机对照试验,旨在评估除 PVI 外 LVA 引导的消融是否优于单独 PVI,用于治疗持续性 AF 和在接受第一次导管消融时检测到 LVA 的患者。
更新日期:2021-09-09
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