Principal Investigator: Leenhapong Navaravong
Keywords: Heart Failure Department: Cardiovascular Medicine
IRB Number: 00094972
Specialty: Cardiology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Jaymee Sanderson
jaymee.sanderson@hsc.utah.edu
801-585-2975

Simple Summary

The primary objective is to understand the roll of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy. The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency.

Inclusion Criteria

 

  • 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 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 the protocol

Exclusion Criteria

  • History of spontaneous sustained VT (≥ 160 bpm at ≥ 30 seconds in duration) or 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 VAD or is to receive 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 

Participant Reimbursement

•History of spontaneous sustained VT (≥ 160 bpm at ≥ 30 seconds in duration) or 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 VAD or is to receive 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