Trop-Shock DFT-testing Versus None

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Defibrillation Testing - ICD Therapy Optimisation

Treatments: Device: Upper limit of vulnerability testing; Device: ICD Implantation without DFT testing; Device: T-wave shock with induction of ventricular fibrillation

Study type: Interventional

Funder types: Other

Identifiers

NCT01230086

GER-EP-005

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Atrial fibrillation with inappropriate anticoagulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

195 participants in 3 patient groups

ICD implantation only

Active Comparator group

Description:

ICD Implantation without testing of defibrillation threshold testing

Treatment:

Device: ICD Implantation without DFT testing

Device: T-wave shock with induction of ventricular fibrillation

Modified upper limit of vulnerability testing

Active Comparator group

Description:

Modified testing of "upper limit of vulnerability"

Treatment:

Device: Upper limit of vulnerability testing

VF-Induction

Active Comparator group

Description:

traditional VF-induction with T-Wave shock

Treatment:

Device: T-wave shock with induction of ventricular fibrillation