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

• ClinicalTrials.gov Identifier: NCT02923726
• Recruitment Status: Active, not recruiting
• First Posted: October 5, 2016
• Last Update Posted: May 5, 2022
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: October 3, 2016
• First Posted Date: October 5, 2016
• Last Update Posted Date: May 5, 2022
• Actual Study Start Date: September 30, 2016
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Sudden Cardiac Death

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 6, 2021): 2603
• Original Estimated Enrollment (submitted: October 4, 2016): 2600
• Estimated Study Completion Date: October 2025
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Canada, Italy, Japan, Korea, Republic of, Spain, United Kingdom, United States
• Removed Location Countries: Portugal

Administrative Information

• NCT Number: NCT02923726
• Other Study ID Numbers: C1924
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Boston Scientific Corporation
• Study Sponsor: Boston Scientific Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Claudio Schuger, M.D.; University of Rochester Clincal Cardiovascular Research Center

• PRS Account: Boston Scientific Corporation
• Verification Date: May 2022