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

Tomoharu Dohi, Daisaku Nakatani, Koichi Inoue, Shungo Hikoso, Takafumi Oka, Kenichi Hayashi, Masaharu Masuda, Yoshio Furukawa, Masato Kawasaki, Yasuyuki Egami, Kazunori Kashiwase, Akio Hirata, Tetsuya Watanabe, Miwa Miyoshi, Toshihiro Takeda, Akito Nakagawa, Hiroya Mizuno, Hitoshi Minamiguchi, Tetsuhisa Kitamura, Shinichiro SunaTakayuki Kojima, Hirota Kida, Oeun Bolrathanak, Yuji Okuyama, Yasushi Sakata

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalJournal of Cardiology
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Pulmonary Veins
Atrial Fibrillation
Catheter Ablation
Recurrence
Randomized Controlled Trials
Cardiac Electrophysiologic Techniques
Health Surveys
Cause of Death
Electrocardiography
Stroke
Quality of Life

Keywords

  • Catheter ablation
  • Non-inferiority trial
  • Persistent atrial fibrillation
  • Recurrence

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial : Design and rationale. / Dohi, Tomoharu; Nakatani, Daisaku; Inoue, Koichi; Hikoso, Shungo; Oka, Takafumi; Hayashi, Kenichi; Masuda, Masaharu; Furukawa, Yoshio; Kawasaki, Masato; Egami, Yasuyuki; Kashiwase, Kazunori; Hirata, Akio; Watanabe, Tetsuya; Miyoshi, Miwa; Takeda, Toshihiro; Nakagawa, Akito; Mizuno, Hiroya; Minamiguchi, Hitoshi; Kitamura, Tetsuhisa; Suna, Shinichiro; Kojima, Takayuki; Kida, Hirota; Bolrathanak, Oeun; Okuyama, Yuji; Sakata, Yasushi.

In: Journal of Cardiology, 01.01.2019.

Research output: Contribution to journalArticle

Dohi, T, Nakatani, D, Inoue, K, Hikoso, S, Oka, T, Hayashi, K, Masuda, M, Furukawa, Y, Kawasaki, M, Egami, Y, Kashiwase, K, Hirata, A, Watanabe, T, Miyoshi, M, Takeda, T, Nakagawa, A, Mizuno, H, Minamiguchi, H, Kitamura, T, Suna, S, Kojima, T, Kida, H, Bolrathanak, O, Okuyama, Y & Sakata, Y 2019, 'Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial: Design and rationale', Journal of Cardiology. https://doi.org/10.1016/j.jjcc.2019.01.010
Dohi, Tomoharu ; Nakatani, Daisaku ; Inoue, Koichi ; Hikoso, Shungo ; Oka, Takafumi ; Hayashi, Kenichi ; Masuda, Masaharu ; Furukawa, Yoshio ; Kawasaki, Masato ; Egami, Yasuyuki ; Kashiwase, Kazunori ; Hirata, Akio ; Watanabe, Tetsuya ; Miyoshi, Miwa ; Takeda, Toshihiro ; Nakagawa, Akito ; Mizuno, Hiroya ; Minamiguchi, Hitoshi ; Kitamura, Tetsuhisa ; Suna, Shinichiro ; Kojima, Takayuki ; Kida, Hirota ; Bolrathanak, Oeun ; Okuyama, Yuji ; Sakata, Yasushi. / Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial : Design and rationale. In: Journal of Cardiology. 2019.
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abstract = "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.",
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T1 - Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial

T2 - Design and rationale

AU - Dohi, Tomoharu

AU - Nakatani, Daisaku

AU - Inoue, Koichi

AU - Hikoso, Shungo

AU - Oka, Takafumi

AU - Hayashi, Kenichi

AU - Masuda, Masaharu

AU - Furukawa, Yoshio

AU - Kawasaki, Masato

AU - Egami, Yasuyuki

AU - Kashiwase, Kazunori

AU - Hirata, Akio

AU - Watanabe, Tetsuya

AU - Miyoshi, Miwa

AU - Takeda, Toshihiro

AU - Nakagawa, Akito

AU - Mizuno, Hiroya

AU - Minamiguchi, Hitoshi

AU - Kitamura, Tetsuhisa

AU - Suna, Shinichiro

AU - Kojima, Takayuki

AU - Kida, Hirota

AU - Bolrathanak, Oeun

AU - Okuyama, Yuji

AU - Sakata, Yasushi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - Catheter ablation

KW - Non-inferiority trial

KW - Persistent atrial fibrillation

KW - Recurrence

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