Shockless Implant Evaluation
To test the hypothesis that ICD implantation without defibrillation testing is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
Randomized, single blind (subject), active control, parallel group design, supportive care.
First occurrence of the composite of failed first appropriate clinical shock from the ICD or arrhythmic death.Secondary Endpoint: Complication rate. All outcome events are adjudicated.
Susan Chrolavicius, Brandi Meeks