Trop-Shock DFT-testing Versus None

Study Overview
=================
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.

Official Title
-----------------
hs Troponin Release in Relation to Different ICD-Implantation Procedures

Conditions
-----------------
Defibrillation Testing - ICD Therapy Optimisation

Intervention / Treatment
-----------------
* Device: ICD Implantation without DFT testing
* Device: Upper limit of vulnerability testing
* Device: T-wave shock with induction of ventricular fibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy Exclusion Criteria: Atrial fibrillation with inappropriate anticoagulation
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICD implantation only<br>ICD Implantation without testing of defibrillation threshold testing | Device: ICD Implantation without DFT testing<br>* Implantation<br>Device: T-wave shock with induction of ventricular fibrillation<br>* Traditional safety margin testing for defibrillation threshold<br>|
| Active Comparator: Modified upper limit of vulnerability testing<br>Modified testing of upper limit of vulnerability | Device: Upper limit of vulnerability testing<br>* Upper limit of vulnerability testing<br>|
| Active Comparator: VF-Induction<br>traditional VF-induction with T-Wave shock | Device: T-wave shock with induction of ventricular fibrillation<br>* Traditional safety margin testing for defibrillation threshold<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, DFT-testing