NCT03526302

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

May 3, 2018

Last Update Submit

March 17, 2023

Conditions

Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

  • High sensitive TroponinT

    Difference between pre- and postoperative high sensitive TroponinT serum levels

    24 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the indication for the implantation of an entirely subcutaneous cardioverter-defibrillator

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

München, 80636, Germany

Location

Related 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-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.

    PMID: 32959177RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christof Kolb, MD

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

April 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

DE(1)