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J-LEX: Japanese Lead Extraction Registry

Sponsor
National Cerebral and Cardiovascular Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04345627
Collaborator
(none)
5,000
Enrollment
1
Location
165
Anticipated Duration (Months)
30.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Japanese Lead Extraction (J-LEX) 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 until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Japanese Lead Extraction Registry
    Actual Study Start Date :
    Jul 1, 2018
    Anticipated Primary Completion Date :
    Mar 31, 2032
    Anticipated Study Completion Date :
    Mar 31, 2032

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of procedural success [Through discharge from hospital, approximately up to 2 weeks.]

      Procedural success was defined as complete or partial and is identified for each lead extracted.

    Secondary Outcome Measures

    1. Number of in-hospital deaths [Through discharge from hospital, approximately up to 2 weeks.]

      All-cause death, cardiovascular death, and procedure-related death

    2. Number of patients with procedure-related complications [4 weeks]

      Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing transvenous lead extraction in Japan.
    Exclusion Criteria:

    • Patients who receive open-chest surgical extraction alone.

    • Patients who refused to consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cerebral and Cardiovascular Center Suita Osaka Japan 564-8565

    Sponsors and Collaborators

    • National Cerebral and Cardiovascular Center

    Investigators

    • Principal Investigator: Kengo Kusano, MD, PhD, National Cerebral and Cardiovascular Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kengo Kusano, Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, National Cerebral and Cardiovascular Center
    ClinicalTrials.gov Identifier:
    NCT04345627
    Other Study ID Numbers:
    • M29-146
    • UMIN000036078
    First Posted:
    Apr 14, 2020
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kengo Kusano, Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, National Cerebral and Cardiovascular Center
    Lead extraction
    Pacemaker
    Defibrillator
    Complication
    REDCap
    Additional relevant MeSH terms:
    Arrhythmias, Cardiac

    Study Results

    No Results Posted as of Apr 6, 2022