At a glance
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Shockless Implant Evaluation
In Brief
A clinical study evaluating Implantable defibrillator for Ventricular Fibrillation and Ventricular Tachycardia. Completed, enrolled 2,500 participants across 85 sites in 18 countries.
Detailed Summary
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death. It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.
Study Details
Timeline
Interventions
Implantable defibrillator to detect and terminate ventricular arrhythmias