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

Boston Scientific

Status: Completed

Conditions: Sudden Cardiac Death

Treatments: Device: Arm 2 (shock only); Device: Arm 1 (ATP+Shock)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02923726

C1924

Details and patient eligibility

About

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.

Enrollment: 2,692 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,692 participants in 2 patient groups

ATP and Shock

Active Comparator group

Description:

Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.

Treatment:

Device: Arm 1 (ATP+Shock)

Shock only

Experimental group

Description:

Once tachycardia has been detected and duration met, this group would receive shock therapy only.

Treatment:

Device: Arm 2 (shock only)