Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP

- Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from
pacemaker to ICD ) implanted because of one of the following:

- Prior MI and left ventricular ejection fraction (LVEF) less than or equal to (≤
)30% OR

- Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35% , and a New York Heart
Association (NYHA) class II or III

- Subject is age 21or above, or is considered of legal age per given geography

- Subject is willing and capable of providing informed consent

- Subject is willing and capable of complying with follow-up visits as defined by this
protocol

Exclusion Criteria:

- History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30
seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause

- NYHA Class IV documented in the medical records within 90 calendar days prior to
enrollment

- Subject is eligible and scheduled for cardiac resynchronization (CRT) implant

- Subjects with a previous subcutaneous ICD (S-ICD)

- Subject with existing TV-ICD device implanted for greater than 60 days

- Subjects with coronary artery bypass graft surgery or percutaneous coronary
intervention within the past 90 calendar days prior to enrollment

- Subjects with documented myocardial infarction within the past 90 calendar days prior
to enrollment

- Subjects on the active heart transplant list

- Subject who has a ventricular assist device (VAD) or is to receive a VAD

- Life expectancy shorter than 18 months due to any medical condition (e.g., cancer,
uremia, liver failure, etc…)

- Subjects currently requiring hemodialysis

- Subject who is known to pregnant or plans to become pregnant over the course of the
trial

- Subject is enrolled in any other concurrent clinical study, with the exception of
local mandatory governmental registries and observational studies/registries, without
the written approval from Boston Scientific