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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
All-Cause Shock	5 years	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. All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. All shocks, appropriate and inappropriate, contributed to the evaluation of this endpoint.

Secondary Outcome Measures

Name	Time	Method
Inappropriate Shock	5 years	incidence of first inappropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Inappropriate shocks contributed to the evaluation of this endpoint.
All-Cause Shock or Death From Any Cause	5 years	incidence of all-cause shocks or death from any cause
Appropriate Shock	5 years	incidence of first appropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Appropriate shocks contributed to the evaluation of this endpoint.
All Cause Mortality	5 years	incidents of all cause mortality

Locations (134): Heart Center Research, LLC
🇺🇸
Huntsville, Alabama, United States
Providence Alaska Medical Center
🇺🇸
Anchorage, Alaska, United States
Tri-City Cardiology
🇺🇸
Mesa, Arizona, United States
Cardiovascular Consultants, LTD
🇺🇸
Phoenix, Arizona, United States
Yuma Regional Medical Center
🇺🇸
Yuma, Arizona, United States
Arrhythmia Research Group
🇺🇸
Jonesboro, Arkansas, United States
Mercy Clinic Cardiology
🇺🇸
Rogers, Arkansas, United States
Comprehensive Cardiovascular Specialists
🇺🇸
Alhambra, California, United States
Scripps Mercy Chula Vista
🇺🇸
Chula Vista, California, United States
VA Loma Linda
🇺🇸
Loma Linda, California, United States
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Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States