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

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ClinicalTrials.gov Identifier: NCT02923726
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Sudden Cardiac Death Device: Arm 1 (ATP+Shock) Device: Arm 2 (shock only) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time-to-First All-Cause Shock [ Time Frame: From 60 days post implant up to five years ]
    Minimum follow up is 18 months and follow up lasts until last patient has completed the 18 month follow up


Secondary Outcome Measures :
  1. • All-cause mortality [ Time Frame: From 60 days post implant up to five years ]
  2. Time to first appropriate shock [ Time Frame: From 60 days post implant up to five years ]
  3. Time to first inappropriate shock [ Time Frame: From 60 days post implant up to five years ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923726


Contacts
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Contact: Jacqueline Beaulieu 1-800-227-3422 jacqueline.beaulieu@bsci.com
Contact: Claudio Schuger, M.D. 313-916-2417 cschuge1@hfhs.org

Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Claudio Schuger, M.D. Henry Ford Health System
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02923726    
Other Study ID Numbers: C1924
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boston Scientific Corporation:
Antitachycardia Pacing Therapy
Shock Therapy
Primary Prevention
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
 Heart Diseases
Cardiovascular Diseases
Death, Sudden