Trop-Shock DFT-testing Versus None

Phase 4

Completed

• Conditions: Defibrillation Testing - ICD Therapy Optimisation

• Registration Number: NCT01230086
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

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

Exclusion Criteria

• Atrial fibrillation with inappropriate anticoagulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Influence of different ICD-implantation strategies on release of high sensitivity Troponin	6 hours

Secondary Outcome Measures

Name	Time	Method
Influence of different ICD-implantation strategies on BNP release	6 hours

Trial Locations

Locations (1)

Technische Universität München; 🇩🇪 München, Bavaria, Germany