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Trop-Shock DFT-testing Versus None (Trop-Shock)

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ClinicalTrials.gov Identifier: NCT01230086
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Defibrillation Testing - ICD Therapy Optimisation Device: ICD Implantation without DFT testing Device: Upper limit of vulnerability testing Device: T-wave shock with induction of ventricular fibrillation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: hs Troponin Release in Relation to Different ICD-Implantation Procedures
Study Start Date : August 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: ICD implantation only
ICD Implantation without testing of defibrillation threshold testing
Device: ICD Implantation without DFT testing
Implantation

Device: T-wave shock with induction of ventricular fibrillation
Traditional safety margin testing for defibrillation threshold

Active Comparator: Modified upper limit of vulnerability testing
Modified testing of "upper limit of vulnerability"
Device: Upper limit of vulnerability testing
Upper limit of vulnerability testing

Active Comparator: VF-Induction
traditional VF-induction with T-Wave shock
Device: T-wave shock with induction of ventricular fibrillation
Traditional safety margin testing for defibrillation threshold




Primary Outcome Measures :
  1. Influence of different ICD-implantation strategies on release of high sensitivity Troponin [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Influence of different ICD-implantation strategies on BNP release [ Time Frame: 6 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy

Exclusion Criteria:

  • Atrial fibrillation with inappropriate anticoagulation

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 ClinicalTrials.gov identifier (NCT number): NCT01230086


Locations
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Germany
Technische Universität München
München, Bavaria, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01230086     History of Changes
Other Study ID Numbers: GER-EP-005
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Deutsches Herzzentrum Muenchen:
ICD
DFT-testing