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

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.