Skip to main content
OpenTrials
Completed

NCT Number: NCT02923726

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitaetsklinikum GmbH, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1 (ATP+Shock)

Device

Subjects will be randomized and device programmed to the respective arm.

Arm 2 (shock only)

Device

Subjects will be randomized and device programmed to the respective arm.

Primary outcomes

  1. All-Cause Shock

    Time frame: 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 outcomes

  1. All-Cause Shock or Death From Any Cause

    Time frame: 5 years

    incidence of all-cause shocks or death from any cause

  2. Appropriate Shock

    Time frame: 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.

  3. Inappropriate Shock

    Time frame: 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.

  4. All Cause Mortality

    Time frame: 5 years

    incidents of all cause mortality

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: APPRAISE ATP

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2016
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.