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

April 10, 2017 updated by: Deutsches Herzzentrum Muenchen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 80636
        • Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Atrial fibrillation with inappropriate anticoagulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influence of different ICD-implantation strategies on release of high sensitivity Troponin
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of different ICD-implantation strategies on BNP release
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (ESTIMATE)

October 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GER-EP-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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