- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526302
TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation (TROPIC)
March 17, 2023 updated by: Deutsches Herzzentrum Muenchen
Register About Change of hsTROPoninT After Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator
Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Severin Weigand, MD
- Phone Number: 2020 +49891218
- Email: weigand@dhm.mhn.de
Study Contact Backup
- Name: Christof Kolb, MD
- Phone Number: 2020 +49891218
- Email: kolb@dhm.mhn.de
Study Locations
-
-
-
München, Germany, 80636
- Deutsches Herzzentrum Munchen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with the indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
Description
Inclusion Criteria:
- Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High sensitive TroponinT
Time Frame: 24 hours
|
Difference between pre- and postoperative high sensitive TroponinT serum levels
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (Actual)
May 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 17, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GER-EP-018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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