Location: Las Vegas
Compensation: No monetary compensation to participant. Patient receives the device.
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 duration of the study, from first enrollment to the last patient’s final visit is expected to be approximately 51 months. Individual patients will be followed from enrollment until their 18 month follow-up visit.