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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 : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE October 3, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date November 8, 2021
Actual Study Start Date  ICMJE September 30, 2016
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • • All-cause mortality [ Time Frame: From 60 days post implant up to five years ]
  • Time to first appropriate shock [ Time Frame: From 60 days post implant up to five years ]
  • Time to first inappropriate shock [ Time Frame: From 60 days post implant up to five years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
Official Title  ICMJE Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Sudden Cardiac Death
Intervention  ICMJE
  • Device: Arm 1 (ATP+Shock)
    Subjects will be randomized and device programmed to the respective arm.
  • Device: Arm 2 (shock only)
    Subjects will be randomized and device programmed to the respective arm.
Study Arms  ICMJE
  • Active Comparator: ATP and Shock
    Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
    Intervention: Device: Arm 1 (ATP+Shock)
  • Experimental: Shock only
    Once tachycardia has been detected and duration met, this group would receive shock therapy only.
    Intervention: Device: Arm 2 (shock only)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 6, 2021)
2603
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
2600
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Italy,   Japan,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT02923726
Other Study ID Numbers  ICMJE C1924
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudio Schuger, M.D. Henry Ford Health System
PRS Account Boston Scientific Corporation
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP