TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

NCT ID: NCT03526302

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sudden Cardiac Death

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christof Kolb, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Deutsches Herzzentrum München

München, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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-defibrillator compared to a conventional transvenous approach: the TROPIC registry. J Interv Card Electrophysiol. 2021 Oct;62(1):75-81. doi: 10.1007/s10840-020-00874-z. Epub 2020 Sep 21.

Reference Type RESULT
PMID: 32959177 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GER-EP-018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.