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TROPIC: TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03526302
Collaborator
(none)
50
Enrollment
1
Location
31
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To analyze the periprocedural myocardial damage the pre- and postoperative assessment of serum levels of high sensitive TroponinT (hsTnT) is done. The main objectives of the TROPIC register are to evaluate the level of high sensitive TroponinT before and after S-ICD device implantation and to compare these changes in TroponinT-levels with those after standard transvenous ICD-implantation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Register About Change of hsTROPoninT After Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator
    Actual Study Start Date :
    Apr 1, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2020
    Anticipated Study Completion Date :
    Oct 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. High sensitive TroponinT [24 hours]

      Difference between pre- and postoperative high sensitive TroponinT serum levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deutsches Herzzentrum München München Germany 80636

    Sponsors and Collaborators

    • Deutsches Herzzentrum Muenchen

    Investigators

    • Principal Investigator: Christof Kolb, MD, Deutsches Herzzentrum München

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deutsches Herzzentrum Muenchen
    ClinicalTrials.gov Identifier:
    NCT03526302
    Other Study ID Numbers:
    • GER-EP-018
    First Posted:
    May 16, 2018
    Last Update Posted:
    May 16, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Death, Sudden, Cardiac
    Death

    Study Results

    No Results Posted as of May 16, 2018