Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD)

rationale and study design

on behalf of the PAUSE-SCD investigators

Research output: Contribution to journalArticle

Abstract

Background: The role of catheter ablation as an adjunct and alternative to ICD implantation is not known in patients at risk for recurrent ventricular tachycardia (VT) and sudden cardiac death (SCD) across Asia. Patients with nonischemic etiologies of cardiomyopathy, which are highly prevalent in Asia, have not been previously enrolled in randomized trials of VT ablation. Objective: To evaluate whether preemptive catheter ablation in patients with monomorphic VT and an indication for ICD implantation results in improved clinical outcomes compared to ICD implantation with standard medical therapy alone. To examine the natural history of ablation outcomes in the absence of background ICD therapy in patients that refuse randomization. Methods: The PAUSE-SCD study (NCT02848781) is a prospective, multi-center, randomized controlled trial enrolling patients with structural heart disease (EF < 50%) with an indication for ICD implantation. Patients are randomized in a 1:1 fashion to two treatment arms: ICD with ablation and ICD with standard medical therapy alone. A prospective registry cohort was designed to follow the outcomes of patients who refuse ICD and randomization but elect to receive catheter ablation as primary therapy. The primary endpoint is defined as a composite of recurrent VT, cardiovascular rehospitalization, and death. Pre-specified secondary endpoints include each of the individual components of the primary endpoint in addition to comparison between randomized and registry patients. Conclusion: The PAUSE-SCD study is a prospective, multi-center, randomized, and controlled trial examining the impact of preemptive catheter ablation on cardiovascular outcomes in patients with an indication for ICD at risk for recurrent VT and SCD. It represents the first multi-center VT ablation study in Asia, with a design intended to provide insights into the role of both ICD and ablation therapy in a predominantly nonischemic population.

Original languageEnglish
JournalJournal of Interventional Cardiac Electrophysiology
DOIs
Publication statusPublished - 2019 Jan 1

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Cardiac Catheters
Catheter Ablation
Sudden Cardiac Death
Ventricular Tachycardia
Random Allocation
Registries
Therapeutics
Randomized Controlled Trials
Natural History
Cardiomyopathies
Heart Diseases

Keywords

  • Catheter ablation
  • ICD implantation
  • Sudden cardiac death

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

@article{5c8072670cc24313a96c5e0e0782c4e1,
title = "Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD): rationale and study design",
abstract = "Background: The role of catheter ablation as an adjunct and alternative to ICD implantation is not known in patients at risk for recurrent ventricular tachycardia (VT) and sudden cardiac death (SCD) across Asia. Patients with nonischemic etiologies of cardiomyopathy, which are highly prevalent in Asia, have not been previously enrolled in randomized trials of VT ablation. Objective: To evaluate whether preemptive catheter ablation in patients with monomorphic VT and an indication for ICD implantation results in improved clinical outcomes compared to ICD implantation with standard medical therapy alone. To examine the natural history of ablation outcomes in the absence of background ICD therapy in patients that refuse randomization. Methods: The PAUSE-SCD study (NCT02848781) is a prospective, multi-center, randomized controlled trial enrolling patients with structural heart disease (EF < 50{\%}) with an indication for ICD implantation. Patients are randomized in a 1:1 fashion to two treatment arms: ICD with ablation and ICD with standard medical therapy alone. A prospective registry cohort was designed to follow the outcomes of patients who refuse ICD and randomization but elect to receive catheter ablation as primary therapy. The primary endpoint is defined as a composite of recurrent VT, cardiovascular rehospitalization, and death. Pre-specified secondary endpoints include each of the individual components of the primary endpoint in addition to comparison between randomized and registry patients. Conclusion: The PAUSE-SCD study is a prospective, multi-center, randomized, and controlled trial examining the impact of preemptive catheter ablation on cardiovascular outcomes in patients with an indication for ICD at risk for recurrent VT and SCD. It represents the first multi-center VT ablation study in Asia, with a design intended to provide insights into the role of both ICD and ablation therapy in a predominantly nonischemic population.",
keywords = "Catheter ablation, ICD implantation, Sudden cardiac death",
author = "{on behalf of the PAUSE-SCD investigators} and Minglong Chen and Shulin Wu and Yan Yao and Jian Jiang and Chenyang Jiang and Yumei Xue and Xianzhang Zhan and Hongde Hu and Guosheng Fu and Kai Gu and Hailei Liu and Ligang Ding and Ruhong Jiang and Chung, {Fa Po} and Lin, {Yenn Jiang} and Yuichi Hori and Yuki Komatsu and Akiko Ueda and Kyoko Soejima and Kim, {Young Hoon} and Akihiko Nogami and Shiro Nakahara and Chen, {Shih Ann} and Roderick Tung",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s10840-019-00535-w",
language = "English",
journal = "Journal of Interventional Cardiac Electrophysiology",
issn = "1383-875X",
publisher = "Springer Netherlands",

}

TY - JOUR

T1 - Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD)

T2 - rationale and study design

AU - on behalf of the PAUSE-SCD investigators

AU - Chen, Minglong

AU - Wu, Shulin

AU - Yao, Yan

AU - Jiang, Jian

AU - Jiang, Chenyang

AU - Xue, Yumei

AU - Zhan, Xianzhang

AU - Hu, Hongde

AU - Fu, Guosheng

AU - Gu, Kai

AU - Liu, Hailei

AU - Ding, Ligang

AU - Jiang, Ruhong

AU - Chung, Fa Po

AU - Lin, Yenn Jiang

AU - Hori, Yuichi

AU - Komatsu, Yuki

AU - Ueda, Akiko

AU - Soejima, Kyoko

AU - Kim, Young Hoon

AU - Nogami, Akihiko

AU - Nakahara, Shiro

AU - Chen, Shih Ann

AU - Tung, Roderick

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: The role of catheter ablation as an adjunct and alternative to ICD implantation is not known in patients at risk for recurrent ventricular tachycardia (VT) and sudden cardiac death (SCD) across Asia. Patients with nonischemic etiologies of cardiomyopathy, which are highly prevalent in Asia, have not been previously enrolled in randomized trials of VT ablation. Objective: To evaluate whether preemptive catheter ablation in patients with monomorphic VT and an indication for ICD implantation results in improved clinical outcomes compared to ICD implantation with standard medical therapy alone. To examine the natural history of ablation outcomes in the absence of background ICD therapy in patients that refuse randomization. Methods: The PAUSE-SCD study (NCT02848781) is a prospective, multi-center, randomized controlled trial enrolling patients with structural heart disease (EF < 50%) with an indication for ICD implantation. Patients are randomized in a 1:1 fashion to two treatment arms: ICD with ablation and ICD with standard medical therapy alone. A prospective registry cohort was designed to follow the outcomes of patients who refuse ICD and randomization but elect to receive catheter ablation as primary therapy. The primary endpoint is defined as a composite of recurrent VT, cardiovascular rehospitalization, and death. Pre-specified secondary endpoints include each of the individual components of the primary endpoint in addition to comparison between randomized and registry patients. Conclusion: The PAUSE-SCD study is a prospective, multi-center, randomized, and controlled trial examining the impact of preemptive catheter ablation on cardiovascular outcomes in patients with an indication for ICD at risk for recurrent VT and SCD. It represents the first multi-center VT ablation study in Asia, with a design intended to provide insights into the role of both ICD and ablation therapy in a predominantly nonischemic population.

AB - Background: The role of catheter ablation as an adjunct and alternative to ICD implantation is not known in patients at risk for recurrent ventricular tachycardia (VT) and sudden cardiac death (SCD) across Asia. Patients with nonischemic etiologies of cardiomyopathy, which are highly prevalent in Asia, have not been previously enrolled in randomized trials of VT ablation. Objective: To evaluate whether preemptive catheter ablation in patients with monomorphic VT and an indication for ICD implantation results in improved clinical outcomes compared to ICD implantation with standard medical therapy alone. To examine the natural history of ablation outcomes in the absence of background ICD therapy in patients that refuse randomization. Methods: The PAUSE-SCD study (NCT02848781) is a prospective, multi-center, randomized controlled trial enrolling patients with structural heart disease (EF < 50%) with an indication for ICD implantation. Patients are randomized in a 1:1 fashion to two treatment arms: ICD with ablation and ICD with standard medical therapy alone. A prospective registry cohort was designed to follow the outcomes of patients who refuse ICD and randomization but elect to receive catheter ablation as primary therapy. The primary endpoint is defined as a composite of recurrent VT, cardiovascular rehospitalization, and death. Pre-specified secondary endpoints include each of the individual components of the primary endpoint in addition to comparison between randomized and registry patients. Conclusion: The PAUSE-SCD study is a prospective, multi-center, randomized, and controlled trial examining the impact of preemptive catheter ablation on cardiovascular outcomes in patients with an indication for ICD at risk for recurrent VT and SCD. It represents the first multi-center VT ablation study in Asia, with a design intended to provide insights into the role of both ICD and ablation therapy in a predominantly nonischemic population.

KW - Catheter ablation

KW - ICD implantation

KW - Sudden cardiac death

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U2 - 10.1007/s10840-019-00535-w

DO - 10.1007/s10840-019-00535-w

M3 - Article

JO - Journal of Interventional Cardiac Electrophysiology

JF - Journal of Interventional Cardiac Electrophysiology

SN - 1383-875X

ER -