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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sudden Cardiac Death

Intervention / Treatment
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* Device: Arm 1 (ATP+Shock)
* Device: Arm 2 (shock only)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ATP and Shock<br>Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. | Device: Arm 1 (ATP+Shock)<br>* Subjects will be randomized and device programmed to the respective arm.<br>|
| Experimental: Shock only<br>Once tachycardia has been detected and duration met, this group would receive shock therapy only. | Device: Arm 2 (shock only)<br>* Subjects will be randomized and device programmed to the respective arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-First All-Cause Shock | Minimum follow up is 18 months and follow up lasts until last patient has completed the 18 month follow up | From 60 days post implant up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • All-cause mortality |  | From 60 days post implant up to five years | 
| Time to first appropriate shock |  | From 60 days post implant up to five years | 
| Time to first inappropriate shock |  | From 60 days post implant up to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antitachycardia Pacing Therapy, Shock Therapy, Primary Prevention