Sudden Cardiac DeathTROPICNCT03526302
TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation
An observational study of Sudden Cardiac Death, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
Who may be able to join
- Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sudden Cardiac Death
- Medical subject headings
- Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
High sensitive TroponinT
Difference between pre- and postoperative high sensitive TroponinT serum levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Apr 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christof Kolb, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526302
- Sponsor's protocol ID
- GER-EP-018
- Acronym
- TROPIC
- Status last verified
- Mar 2023
- First submitted
- 3 May 2018
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32959177
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register About Change of hsTROPoninT After Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator
- ClinicalTrials.gov ID
- NCT03526302
- Acronym / sponsor ID
- TROPIC / GER-EP-018
- Conditions
- Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
Key inclusion criteria (1 listed)
- Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
High sensitive TroponinT
Time frame: 24 hours
Difference between pre- and postoperative high sensitive TroponinT serum levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Results publication: PubMed 32959177Weigand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christof Kolb, MD principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High sensitive TroponinT (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.