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Japanese Catheter Ablation Registry (J-AB)

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ClinicalTrials.gov Identifier: NCT03729232
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Kengo Kusano, National Cerebral and Cardiovascular Center

Study Description
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Brief 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.

Condition or disease
Catheter Ablation Cardiac Arrhythmias

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 Design
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Study Type : Observational
Estimated Enrollment : 400000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Japanese Catheter Ablation Registry
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 31, 2030
Estimated Study Completion Date : March 31, 2030
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with recurrence of targeted arrhythmia [ Time Frame: Through discharge from hospital, approximately up to 1 weeks ]

Secondary Outcome Measures :
  1. Number of deaths [ Time Frame: Through discharge from hospital, approximately up to 1 weeks ]
    All-cause death, cardiovascular death, and procedure-related death

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients
Criteria

Inclusion Criteria:

  • Patients treated with catheter ablation in Japan

Exclusion Criteria:

  • Patients who refused to consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729232


Contacts
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Contact: Kengo Kusano, MD, PhD +81-6-6833-5012 kusanokengo@ncvc.go.jp

Locations
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Japan
National Cerebral and Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Kengo Kusano, MD, PhD    +81-6-6833-5012    kusanokengo@ncvc.go.jp   
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Investigators
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Principal Investigator: Teiichi Yamane, MD, PhD The Jikei University School of Medicine
Principal Investigator: Kengo Kusano, MD, PhD National Cerebral and Cardiovascular Center
More Information
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Responsible Party: Kengo Kusano, Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT03729232     History of Changes
Other Study ID Numbers: M28-114
UMIN000028288 ( Other Identifier: UMIN-CTR )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kengo Kusano, National Cerebral and Cardiovascular Center:
Catheter Ablation
Cardiac Arrhythmias
Registry
Complication
REDCap

Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes