Japanese Catheter Ablation Registry (J-AB)

April 5, 2022 updated by: Kengo Kusano, National Cerebral and Cardiovascular Center
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

400000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • National Cerebral and Cardiovascular Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients

Description

Inclusion Criteria:

  • Patients treated with catheter ablation in Japan

Exclusion Criteria:

  • Patients who refused to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with recurrence of targeted arrhythmia
Time Frame: Through discharge from hospital, approximately up to 1 weeks
Through discharge from hospital, approximately up to 1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of deaths
Time Frame: Through discharge from hospital, approximately up to 1 weeks
All-cause death, cardiovascular death, and procedure-related death
Through discharge from hospital, approximately up to 1 weeks
Number of patients with treatment-related complications
Time Frame: 3 months
Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center

Investigators

  • Principal Investigator: Kengo Kusano, MD, PhD, National Cerebral and Cardiovascular Center
  • Principal Investigator: Teiichi Yamane, MD, PhD, The Jikei University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

March 31, 2030

Study Completion (Anticipated)

March 31, 2030

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M28-114
  • UMIN000028288 (Other Identifier: UMIN-CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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