At a glance
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Evaluating Myocardial Injury During ICD Implantation Using the Upper Limit of Vulnerability (ULV) Method vs. Standard Defibrillation Threshold Testing
In Brief
A clinical study evaluating Standard Defibrillation Testing and Upper Limit of Vulnerability Testing for Cardiomyopathy and 2 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV) method vs. standard defibrillation threshold method.
Study Details
Timeline
Interventions
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.
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.