Trop-Shock DFT-testing Versus None

NCT01230086 | Completed Phase 4

• 1 other identifier: GER-EP-005
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Defibrillation Testing - ICD Therapy Optimisation

Keywords

ICD; DFT-testing

Outcome Measures

Primary Outcomes (1)

• Influence of different ICD-implantation strategies on release of high sensitivity Troponin

  6 hours

Secondary Outcomes (1)

• Influence of different ICD-implantation strategies on BNP release

  6 hours

Study Arms (3)

ICD implantation only

ACTIVE COMPARATOR

ICD Implantation without testing of defibrillation threshold testing

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

Modified upper limit of vulnerability testing

ACTIVE COMPARATOR

Modified testing of "upper limit of vulnerability"

Device: Upper limit of vulnerability testing

VF-Induction

ACTIVE COMPARATOR

traditional VF-induction with T-Wave shock

Device: T-wave shock with induction of ventricular fibrillation

Interventions

ICD Implantation without DFT testing DEVICE

Implantation

ICD implantation only

Upper limit of vulnerability testing DEVICE

Upper limit of vulnerability testing

Modified upper limit of vulnerability testing

T-wave shock with induction of ventricular fibrillation DEVICE

Traditional safety margin testing for defibrillation threshold

ICD implantation only; VF-Induction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Atrial fibrillation with inappropriate anticoagulation

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Technische Universität München

München, Bavaria, 80636, Germany

Location

Related Publications (1)

• Semmler V, Biermann J, Haller B, Jilek C, Sarafoff N, Lennerz C, Vrazic H, Zrenner B, Asbach S, Kolb C. ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing--The Prospective, Randomized, Multicentre TropShock-Trial. PLoS One. 2015 Jul 24;10(7):e0131570. doi: 10.1371/journal.pone.0131570. eCollection 2015.

  PMID: 26208329 DERIVED

Related Links

• Publication Trop-Shock-Study

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

DE (1)