Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial: Design and rationale

被引：15

作者：

Dohi, Tomoharu ^{[1
]}

Nakatani, Daisaku ^{[1
]}

Inoue, Koichi ^{[2
]}

Hikoso, Shungo ^{[1
,3
]}

Oka, Takafumi ^{[2
]}

Hayashi, Kenichi ^{[4
]}

Masuda, Masaharu ^{[5
]}

Furukawa, Yoshio ^{[6
]}

Kawasaki, Masato ^{[6
]}

Egami, Yasuyuki ^{[7
]}

Kashiwase, Kazunori ^{[8
]}

Hirata, Akio ^{[8
]}

Watanabe, Tetsuya ^{[9
]}

Miyoshi, Miwa ^{[10
]}

Takeda, Toshihiro ^{[11
]}

Nakagawa, Akito ^{[11
]}

Mizuno, Hiroya ^{[1
]}

Minamiguchi, Hitoshi ^{[1
]}

Kitamura, Tetsuhisa ^{[12
]}

Suna, Shinichiro ^{[1
]}

Kojima, Takayuki ^{[1
]}

Kida, Hirota ^{[1
]}

Bolrathanak, Oeun ^{[1
]}

Okuyama, Yuji ^{[13
]}

Sakata, Yasushi ^{[1
]}

机构：

[1] Osaka Univ, Dept Cardiovasc Med, Grad Sch Med, 2-2 Yamadaoka, Suita, Osaka 5650871, Japan

[2] Sakurabashi Watanabe Hosp, Cardiovasc Ctr, Osaka, Japan

[3] Osaka Univ, Dept Med Therapeut Heart Failure, Grad Sch Med, Suita, Osaka, Japan

[4] Keio Univ, Dept Math, Yokohama, Kanagawa, Japan

[5] Kansa Rosai Hosp, Cardiovasc Ctr, Amagasaki, Hyogo, Japan

[6] Osaka Gen Med Ctr, Div Cardiol, Osaka, Japan

[7] Osaka Rosai Hosp, Div Cardiol, Sakai, Osaka, Japan

[8] Osaka Police Hosp, Cardiovasc Div, Osaka, Japan

[9] Yao Municipal Hosp, Dept Cardiovasc Med, Yao, Japan

[10] Japan Community Healthcare Org, Osaka Hosp, Dept Cardiol, Osaka, Japan

[11] Osaka Univ, Dept Med Informat, Grad Sch Med, Suita, Osaka, Japan

[12] Osaka Univ, Dept Social & Environm Med, Dept Environm Med & Populat Sci, Grad Sch Med, Suita, Osaka, Japan

[13] Osaka Minami Med Ctr, Cardiovasc Div, Kawachi Nagano, Japan

来源：

JOURNAL OF CARDIOLOGY | 2019年 / 74卷 / 02期

关键词：

Persistent atrial fibrillation; Catheter ablation; Recurrence; Non-inferiority trial; CATHETER ABLATION; ADENOSINE-TRIPHOSPHATE; EFFICACY; EPIDEMIOLOGY; MANAGEMENT; WARFARIN; AF;

D O I：

10.1016/j.jjcc.2019.01.010

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Although extensive substrate modification in addition to pulmonary vein isolation (PVI) has been recommended in catheter ablation for persistent atrial fibrillation (AF), recent randomized controlled trials have not demonstrated efficacy of such additional ablations. Methods and study design: The Osaka Cardiovascular Conference will conduct a multicenter, randomized, open-label trial aiming to examine whether PVI alone is non-inferior to PVI plus additional ablation such as linear ablation and/or complex fractionated atrial electrogram ablation in patients with persistent AF. The primary outcome is recurrence of AF documented by scheduled or symptom-driven electrocardiogram tests during a 1-year follow-up period after the index ablation. The key secondary endpoints include all-cause death, occurrence of symptomatic stroke, complications related to the procedure, and quality of life assessment using the 36-item Short-Form Health Survey. The clinical impact of the presence or absence of AF trigger foci, and their origins in cases with them, on the results of catheter ablation will also be investigated as an exploratory endpoint. A total of 512 patients will be enrolled and followed up to 1 year. Conclusions: The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation. (C) 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

引用

页码：164 / 168

页数：5

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