Japanese Catheter Ablation Registry

Catheter Ablation Clinical Trial

— J-AB  

Official title:

Japanese Catheter Ablation Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729232
• Other study ID #: M28-114
• Secondary ID: UMIN000028288
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: March 31, 2030

Study information

• Verified date: November 2023
• Source: National Cerebral and Cardiovascular Center, Japan
• Contact: Kengo Kusano, MD, PhD
• Phone: +81-6-6170-1070
• Email: kusanokengo[@]ncvc.go.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Japanese Cather Ablation (J-AB) Registry is a voluntary nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The objectives of this registry are to observe and describe developments in the catheter ablation treatment of arrhythmia in Japan and to provide reliable information on the type of activity performed and the facilities available in Japanese arrhythmia units.

Description:

Japanese Cather Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, 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 at 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400000
• Est. completion date: March 31, 2030
• Est. primary completion date: March 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients treated with catheter ablation in Japan

Exclusion Criteria:

• Patients who refused to consent

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias
• Catheter Ablation

Locations

Country	Name	City	State
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with recurrence of targeted arrhythmia		Through discharge from hospital, approximately up to 1 weeks
Secondary	Number of deaths	All-cause death, cardiovascular death, and procedure-related death	Through discharge from hospital, approximately up to 1 weeks
Secondary	Number of patients with treatment-related complications	Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.	3 months