Defibrillation Testing - ICD Therapy Optimisation
Conditions
Keywords
ICD, DFT-testing
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.
Interventions
DEVICEICD Implantation without DFT testing
Implantation
Upper limit of vulnerability testing
DEVICET-wave shock with induction of ventricular fibrillation
Traditional safety margin testing for defibrillation threshold
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy
Exclusion criteria
* Atrial fibrillation with inappropriate anticoagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Influence of different ICD-implantation strategies on release of high sensitivity Troponin | 6 hours |
Secondary
| Measure | Time frame |
|---|---|
| Influence of different ICD-implantation strategies on BNP release | 6 hours |
Countries
Germany
Outcome results
None listed