Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

April 30, 2015

Study Completion Date

June 30, 2015

Conditions
CardiomyopathyHeart FailureCardiac Arrhythmia
Interventions
DEVICE

Standard Defibrillation Testing

Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.

DEVICE

Upper Limit of Vulnerability Testing

Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.

Trial Locations (1)

92093

UCSD Sulpizio Cardiovascular Center, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

University of California, San Diego

OTHER

NCT02111993 - Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation | Biotech Hunter | Biotech Hunter