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日本全国导管消融登记研究设计:一项前瞻性、多中心、开放性登记研究方案。

Study design of nationwide Japanese Catheter Ablation Registry: Protocol for a prospective, multicenter, open registry.

作者信息

Yamane Teiichi, Inoue Koichi, Kusano Kengo, Takegami Misa, Nakao Yoko M, Miyamoto Yoshihiro, Goya Masahiko, Uno Kikuya, Shoda Morio, Murakawa Yuji, Hirao Kenzo, Nogami Akihiko

机构信息

Division of Cardiology Department of Internal Medicine The Jikei University School of Medicine Tokyo Japan.

Cardiovascular Center Sakurabashi Watanabe Hospital Osaka Japan.

出版信息

J Arrhythm. 2019 Feb 4;35(2):167-170. doi: 10.1002/joa3.12163. eCollection 2019 Apr.

Abstract

BACKGROUND

Catheter ablation has become a popular interventional treatment for cardiac tachyarrhythmias and the number has been on the rise year by year. However, little is known about its efficacy and safety in the real-world settings.

METHOD

Japanese Catheter Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society (JHRS), collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the Event Assessment Committee. This registry started in August 2017 and the number of participating medical instructions will be more than 250 hospitals and the target procedure number will be 70 000 per year. We will also compare the results with other registries in foreign countries.

RESULT

The results of this study are currently under investigation.

CONCLUSION

The J-AB registry will provide a real-world data regarding the acute success and complications in Japan, focusing on various types of catheter ablation for cardiac arrhythmias.

摘要

背景

导管消融已成为治疗心脏快速性心律失常的一种流行的介入治疗方法,且其数量逐年上升。然而,对于其在实际临床环境中的疗效和安全性知之甚少。

方法

日本导管消融(J-AB)注册研究是一项由日本心律协会(JHRS)开展、与国立脑神经和心血管中心合作的全国性、多中心观察性注册研究。本研究是一项全国性自愿注册研究,使用研究电子数据采集(REDCap)系统前瞻性收集数据。每年9月还会进行包括抗心律失常药物在内的详细数据收集。所有病例均会收集出院时的急性成功率以及与消融手术相关的并发症。主要出血事件根据出血学术研究联盟标准进行定义。根据所提供的信息,事件评估委员会将调查结局的年发病率和预测因素。该注册研究于2017年8月启动,参与的医疗机构数量将超过250家,每年的目标手术例数将达到70000例。我们还将把结果与国外的其他注册研究进行比较。

结果

本研究结果目前正在调查中。

结论

J-AB注册研究将提供有关日本急性成功率和并发症的真实世界数据,重点关注各种类型的心律失常导管消融。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e9e/6457368/12c2efc3ee16/JOA3-35-167-g001.jpg

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Clinical and procedural predictors of early complications of ablation for atrial fibrillation: analysis of the national registry data.
Heart Rhythm. 2014 Dec;11(12):2247-53. doi: 10.1016/j.hrthm.2014.08.021. Epub 2014 Aug 15.

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