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Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD): rationale and study design

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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.

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Authors and Affiliations

  1. Jiangsu Province Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China

    Minglong Chen, Kai Gu & Hailei Liu

  2. Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China

    Shulin Wu, Yumei Xue & Xianzhang Zhan

  3. Fuwai Cardiovascular Hospital, Beijing, China

    Yan Yao & Ligang Ding

  4. West China Hospital, Si Chuan University, Chengdu, China

    Jian Jiang & Hongde Hu

  5. Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China

    Chenyang Jiang, Guosheng Fu & Ruhong Jiang

  6. School of Medicine, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan

    Fa-Po Chung, Yenn-Jiang Lin & Shih-Ann Chen

  7. Saitama Medical Center, Dokkyo Medical University, Mibu, Japan

    Yuichi Hori & Shiro Nakahara

  8. University of Tsukuba, Tsukuba, Japan

    Yuki Komatsu & Akihiko Nogami

  9. Department of Cardiology, Kyorin University Hospital, Mitaka, Japan

    Akiko Ueda & Kyoko Soejima

  10. Korea University Anam Hospital, Seoul, South Korea

    Young Hoon Kim

  11. Center for Arrhythmia Care, Pritzker School of Medicine, The University of Chicago Medicine, 5841 S. Maryland Ave. MC 6080, Chicago, IL, 60637, USA

    Roderick Tung

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  1. Minglong Chen
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  2. Shulin Wu
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  3. Yan Yao
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  4. Jian Jiang
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  8. Hongde Hu
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on behalf of the PAUSE-SCD investigators

Corresponding author

Correspondence to Roderick Tung.

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Chen, M., Wu, S., Yao, Y. et al. Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD): rationale and study design. J Interv Card Electrophysiol 57, 271–278 (2020). https://doi.org/10.1007/s10840-019-00535-w

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  • DOI: https://doi.org/10.1007/s10840-019-00535-w

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