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

Purpose

The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for 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

  • Sudden Cardiac Death

Eligibility

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

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 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

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