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TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation (TROPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03526302
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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

Condition or disease
Sudden Cardiac Death

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.

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Study Type : Observational
Estimated 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 : April 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 31, 2020

Primary Outcome Measures :
  1. High sensitive TroponinT [ Time Frame: 24 hours ]
    Difference between pre- and postoperative high sensitive TroponinT serum levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the indication for the implantation of an entirely subcutaneous cardioverter-defibrillator

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03526302

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Contact: Severin Weigand, MD +49891218 ext 2020
Contact: Christof Kolb, MD +49891218 ext 2020

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Deutsches Herzzentrum München Recruiting
München, Germany, 80636
Contact: Severin Weigand, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Principal Investigator: Christof Kolb, MD Deutsches Herzzentrum München

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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT03526302     History of Changes
Other Study ID Numbers: GER-EP-018
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden