Location: Las Vegas
Smokers Allowed: Yes
The primary objective is to assess the 18-month incidence of shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bmp and:
- an indication for implantation of a defibrillator for primary prevention of sudden cardiac death;
- a left ventricular ejection fraction ≤ 35%.
The 18-month incidence rate will be compared to an Objective Performance Criteria derived from transvenous ICDs programmed to minimize shocks in the MADIT RIT study.
The secondary objective is to assess perioperative complications.
Device and procedure related complications at 6 months and implant success rate at 3 months will be assessed to fulfill Post Market Clinical Follow-up (PMCF) requirements.