Defibrillation Testing - ICD Therapy OptimisationPhase 4Trop-ShockNCT01230086
Trop-Shock DFT-testing Versus None
A Phase 4 study testing ICD Implantation without DFT testing, Upper limit of vulnerability testing and T-wave shock with induction of ventricular fibrillation in people with Defibrillation Testing - ICD Therapy Optimisation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Defibrillation Testing - ICD Therapy Optimisation
- What is being tested?
- ICD Implantation without DFT testing, Upper limit of vulnerability testing and T-wave shock with induction of ventricular fibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Jun 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy
Who cannot join
- Atrial fibrillation with inappropriate anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: hs Troponin Release in Relation to Different ICD-Implantation Procedures
Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Modern implantation strategies suggest a non-testing approach because net-benefit of a testing versus a non-testing strategy is questionable and because arrhythmia induction and defibrillation may cause micro damage to the heart.
The study aims to investigate the contribution of different steps in the ICD implantation procedure (implantation of the lead, shock delivery and induced ventricular fibrillation) with respect to their potential damage to the heart measured by high sensitivity (HS) TroponinT.
- Being tested
- ICD Implantation without DFT testing, Upper limit of vulnerability testing, T-wave shock with induction of ventricular fibrillation
- Keywords
- ICD, DFT-testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD Implantation without DFT testingDevice
Implantation
Upper limit of vulnerability testingDevice
Upper limit of vulnerability testing
T-wave shock with induction of ventricular fibrillationDevice
Traditional safety margin testing for defibrillation threshold
| Study group | Role | What they receive |
|---|---|---|
| ICD implantation only | Active comparator | ICD Implantation without testing of defibrillation threshold testing Receives: Device: ICD Implantation without DFT testing; Device: T-wave shock with induction of ventricular fibrillation |
| Modified upper limit of vulnerability testing | Active comparator | Modified testing of "upper limit of vulnerability" Receives: Device: Upper limit of vulnerability testing |
| VF-Induction | Active comparator | traditional VF-induction with T-Wave shock Receives: Device: T-wave shock with induction of ventricular fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of different ICD-implantation strategies on release of high sensitivity Troponin
Measured: 6 hours
Secondary outcomes (1)
Influence of different ICD-implantation strategies on BNP release
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2013
- Study completionJun 2013
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 Defibrillation Testing - ICD Therapy OptimisationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230086
- Sponsor's protocol ID
- GER-EP-005
- Acronym
- Trop-Shock
- Status last verified
- Apr 2017
- First submitted
- 26 Oct 2010
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Semmler V, Biermann J, Haller B, Jilek C, Sarafoff N, Lennerz C, Vrazic H, Zrenner B, Asbach S, Kolb C. ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing--The Prospective, Randomized, Multicentre TropShock-Trial. PLoS One. 2015 Jul 24;10(7):e0131570. doi: 10.1371/journal.pone.0131570. eCollection 2015.
PubMed 26208329
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- hs Troponin Release in Relation to Different ICD-Implantation Procedures
- ClinicalTrials.gov ID
- NCT01230086
- Acronym / sponsor ID
- Trop-Shock / GER-EP-005
- Keywords
- ICD, DFT-testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Oct 2010 (estimated)
- 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.
Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Modern implantation strategies suggest a non-testing approach because net-benefit of a testing versus a non-testing strategy is questionable and because arrhythmia induction and defibrillation may cause micro damage to the heart.
The study aims to investigate the contribution of different steps in the ICD implantation procedure (implantation of the lead, shock delivery and induced ventricular fibrillation) with respect to their potential damage to the heart measured by high sensitivity (HS) TroponinT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICD implantation only | Active comparator | Device: ICD Implantation without DFT testing, Device: T-wave shock with induction of ventricular fibrillationICD Implantation without testing of defibrillation threshold testing |
| Modified upper limit of vulnerability testing | Active comparator | Device: Upper limit of vulnerability testingModified testing of "upper limit of vulnerability" |
| VF-Induction | Active comparator | Device: T-wave shock with induction of ventricular fibrillationtraditional VF-induction with T-Wave shock |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy
Key exclusion criteria (1 listed)
- Atrial fibrillation with inappropriate anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD Implantation without DFT testingImplantation | Device | ICD implantation only |
| Upper limit of vulnerability testingUpper limit of vulnerability testing | Device | Modified upper limit of vulnerability testing |
| T-wave shock with induction of ventricular fibrillationTraditional safety margin testing for defibrillation threshold | Device | ICD implantation only, VF-Induction |
Primary outcome
Influence of different ICD-implantation strategies on release of high sensitivity Troponin
Time frame: 6 hours
1 secondary outcome
Influence of different ICD-implantation strategies on BNP release
Time frame: 6 hours
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 12 Apr 2017.
- Derived from this study: PubMed 26208329Semmler V, Biermann J, Haller B, Jilek C, Sarafoff N, Lennerz C, Vrazic H, Zrenner B, Asbach S, Kolb C. ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing--The Prospective, Randomized, Multicentre TropShock-Trial. PLoS One. 2015 Jul 24;10(7):e0131570. doi: 10.1371/journal.pone.0131570. eCollection 2015.
- Publication Trop-Shock-StudyLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICD Implantation without DFT testing, Upper limit of vulnerability testing and T-wave shock with induction of ventricular fibrillation in people with Defibrillation Testing - ICD Therapy Optimisation, 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 12 Apr 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Influence of different ICD-implantation strategies on release of high sensitivity Troponin (time frame: 6 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 NCT01230086, 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 12 Apr 2017.