Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
195 participants
INTERVENTIONAL
2010-08-31
2013-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICD implantation only
ICD Implantation without testing of defibrillation threshold testing
ICD Implantation without DFT testing
Implantation
T-wave shock with induction of ventricular fibrillation
Traditional safety margin testing for defibrillation threshold
Modified upper limit of vulnerability testing
Modified testing of "upper limit of vulnerability"
Upper limit of vulnerability testing
Upper limit of vulnerability testing
VF-Induction
traditional VF-induction with T-Wave shock
T-wave shock with induction of ventricular fibrillation
Traditional safety margin testing for defibrillation threshold
Interventions
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ICD Implantation without DFT testing
Implantation
Upper limit of vulnerability testing
Upper limit of vulnerability testing
T-wave shock with induction of ventricular fibrillation
Traditional safety margin testing for defibrillation threshold
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Locations
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Technische Universität München
München, Bavaria, Germany
Countries
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References
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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.
Related Links
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Publication Trop-Shock-Study
Other Identifiers
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GER-EP-005
Identifier Type: -
Identifier Source: org_study_id
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