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Trop-Shock DFT-testing Versus None

NCT01230086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2017-04-12

No results posted yet for this study

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.

Conditions

  • Defibrillation Testing - ICD Therapy Optimisation

Interventions

DEVICE

ICD Implantation without DFT testing

Implantation

DEVICE

Upper limit of vulnerability testing

Upper limit of vulnerability testing

DEVICE

T-wave shock with induction of ventricular fibrillation

Traditional safety margin testing for defibrillation threshold

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230086 on ClinicalTrials.gov