Last updated on June 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sudden Cardiac Death
  • Age: Between 21 - 100 Years
  • Gender: Male or Female

  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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