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NCT03526302 Clinical Trial

TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

Sudden Cardiac Death Clinical Trial

— TROPIC  

Official title:
Register About Change of hsTROPoninT After Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03526302
Other study ID # GER-EP-018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date September 30, 2020

Study information
Verified date March 2023
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Deutsches Herzzentrum München München

Sponsors (1)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Weigand S, O'Connor M, Blazek P, Kantenwein V, Friedrich L, Grebmer C, Schaarschmidt C, von Olshausen G, Reents T, Deisenhofer I, Lennerz C, Kolb C. Release of high-sensitive TROPonin T by implantation of an entirely subcutaneous Implantable Cardioverter- — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary High sensitive TroponinT Difference between pre- and postoperative high sensitive TroponinT serum levels 24 hours
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