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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 : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Kengo Kusano, National Cerebral and Cardiovascular Center

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 2, 2018
Last Update Posted Date April 14, 2020
Actual Study Start Date July 1, 2017
Estimated Primary Completion Date March 31, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
Number of patients with recurrence of targeted arrhythmia [ Time Frame: Through discharge from hospital, approximately up to 1 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 1, 2018)
  • Number of deaths [ Time Frame: Through discharge from hospital, approximately up to 1 weeks ]
    All-cause death, cardiovascular death, and procedure-related death
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Japanese Catheter Ablation Registry
Official Title Japanese Catheter Ablation Registry
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients
Condition
  • Catheter Ablation
  • Cardiac Arrhythmias
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2018)
400000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2030
Estimated Primary Completion Date March 31, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients treated with catheter ablation in Japan

Exclusion Criteria:

  • Patients who refused to consent
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Kengo Kusano, MD, PhD +81-6-6170-1070 kusanokengo@ncvc.go.jp
Contact: Misa Takegami, PhD, MPH +81-6-6170-1070 takegami@ncvc.go.jp
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03729232
Other Study ID Numbers M28-114
UMIN000028288 ( Other Identifier: UMIN-CTR )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Kengo Kusano, National Cerebral and Cardiovascular Center
Study Sponsor National Cerebral and Cardiovascular Center
Collaborators Not Provided
Investigators
Principal Investigator: Teiichi Yamane, MD, PhD The Jikei University School of Medicine
Principal Investigator: Kengo Kusano, MD, PhD National Cerebral and Cardiovascular Center
PRS Account National Cerebral and Cardiovascular Center
Verification Date April 2020