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Purpose

The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 myocardial infarction (MI) and left ventricular ejection fraction (LVEF) ≤ 30% OR - Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35%, and a New York Heart Association (NYHA) class II or III - Subject is age 21 or 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 transvenous ICD (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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
ATP and Shock 		Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
  • Device: Arm 1 (ATP+Shock)
    Subjects will be randomized and device programmed to the respective arm.
Experimental
Shock only 		Once tachycardia has been detected and duration met, this group would receive shock therapy only.
  • Device: Arm 2 (shock only)
    Subjects will be randomized and device programmed to the respective arm.

More Details

Status
Completed
Sponsor
Boston Scientific Corporation

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.