NCT01230086

Trop-Shock DFT-testing Versus None

hs Troponin Release in Relation to Different ICD-Implantation Procedures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2010-10-28
• Last updated: 2017-04-12

Locations

1 site across 1 country: Germany