TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

Completed

• Conditions: Sudden Cardiac Death

• Registration Number: NCT03526302
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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

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 Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High sensitive TroponinT	24 hours	Difference between pre- and postoperative high sensitive TroponinT serum levels

Trial Locations

Locations (1)

Deutsches Herzzentrum München; 🇩🇪 München, Germany