Skip to main content
OpenTrials
Completed

NCT Number: NCT01230086

Trop-Shock DFT-testing Versus None

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Defibrillation Testing - ICD Therapy Optimisation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Technische Universität München

München, Bavaria, 80636, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Atrial fibrillation with inappropriate anticoagulation

Treatment and study plan

ICD Implantation without DFT testing

Device

Implantation

Upper Limit of Vulnerability Testing

Device

Upper limit of vulnerability testing

T-wave shock with induction of ventricular fibrillation

Device

Traditional safety margin testing for defibrillation threshold

Primary outcomes

  1. Influence of different ICD-implantation strategies on release of high sensitivity Troponin

    Time frame: 6 hours

Secondary outcomes

  1. Influence of different ICD-implantation strategies on BNP release

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

hs Troponin Release in Relation to Different ICD-Implantation Procedures

Acronym: Trop-Shock

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2010
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.