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

April 1, 2024 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Kepler Universitaetsklinikum GmbH
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Royal Columbian Hospital
      • Victoria, British Columbia, Canada, V8T 1Z4
        • Victoria Cardiac Arrhythmia Trials, Inc.
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Scarborough, Ontario, Canada, M1B 4Z8
        • Scarborough Health Network-Centenary Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de l'Université de Montréal
      • Montréal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
      • Quebec City, Quebec, Canada, G1V 4G5
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec.
  • Italy
      • Napoli, Italy, 80100
        • Presidio Ospedale San Giovanni Bosco
      • Napoli, Italy, 80123
        • Hospital Buon Consiglio
      • Napoli, Italy, 8133
        • Ospedale dei Pellegrini
      • Rome, Italy, 00189
        • Az. Osp. S. Andrea
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
        • Policlinico di Modena
    • Southern Cluster
      • Pozzuoli, Southern Cluster, Italy, 80018
        • Osp. Civile S. Maria Delle Grazie
  • Japan
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8677
        • Chiba University Hospital
    • Fukuoka
      • Kitakyushu-Shi, Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
    • Kumamoto,
      • Kumamoto-shi, Kumamoto,, Japan, 860-8556
        • Kumamoto University Hospital
    • Kyoto-shi,
      • Kyoto, Kyoto-shi,, Japan, 606-8507
        • Kyoto University Hospital
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-8621
        • Tachikawa General Hospital
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • National Crebral and Cardiovascular Center Hospital
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Cnter
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Donggu
      • Gwangju, Donggu, Korea, Republic of, 501-757
        • Chonnam National University
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14754
        • Sejong General Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Gyeongsang
      • Yangsan, Gyeongsang, Korea, Republic of, 50612,
        • Pusan National University Yangsan Hospital
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Madrid, Spain, 28046
        • Hospital La Paz
      • San Sebastián, Spain, 20014
        • Hospital Donostia
  • United Kingdom
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest - LHCH
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Tri-City Cardiology
      • Phoenix, Arizona, United States, 85032
        • Cardiovascular Consultants, Ltd
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group
      • Rogers, Arkansas, United States, 72758
        • Mercy Clinic Cardiology
    • California
      • Alhambra, California, United States, 91801
        • Comprehensive Cardiovascular Specialists
      • Chula Vista, California, United States, 91910
        • Scripps Mercy Chula Vista
      • Loma Linda, California, United States, 92357
        • VA Loma Linda
      • Los Angeles, California, United States, 90024
        • Cardiovascular Consultants Medical Group
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates PC
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Cardiac Specialists
      • Stamford, Connecticut, United States, 06902
        • Stamford Hospital
    • Delaware
      • Newark, Delaware, United States, 19805
        • Christiana Hospital
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Cardiology
      • Gainesville, Florida, United States, 32605
        • The Cardiac and Vascular Institute Research Foundation
      • Jacksonville, Florida, United States, 32204
        • St Vincent's Medical Center
      • Lady Lake, Florida, United States, 32159
        • Heart of the Villages
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Research, Inc
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Heart & Vascular
      • Rockledge, Florida, United States, 32955
        • Brevard Cardiovascular Research Associates, Inc
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, United States, 33624
        • AdventHeatlh Tampa
    • Illinois
      • Chicago, Illinois, United States, 60605
        • CorVita Science Foundation
      • Chicago, Illinois, United States, 60612
        • Adventist Hinsdale Hospital
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Medical Group
      • Muncie, Indiana, United States, 47303
        • Ball Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
      • West Des Moines, Iowa, United States, 50266
        • Mercy Hospital Medical Center
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Overland Park Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21237
        • Union Memorial Hospital
      • Salisbury, Maryland, United States, 21804
        • Richard A. Henson Research Institute of Peninsula Regional Medical Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Hospital
      • Fall River, Massachusetts, United States, 02720
        • Southcoast Physicians Group
      • Leominster, Massachusetts, United States, 01453
        • Mass Heart and Rhythm
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Flint, Michigan, United States, 48532
        • Cardiology Consultants of East Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Western Michigan University - Homer Stryker M.D. School of Medicine
      • Saint Joseph, Michigan, United States, 49085
        • Great Lakes Heart & Vascular Institute
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
      • Ypsilanti, Michigan, United States, 48197
        • St. Joseph Mercy Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital of Duluth
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Heart and Vascular Hattiesburg Clinic
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Cox Health
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • The Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates of the Delaware Valley.
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Region Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical University
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Memorial Mission Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Steubenville, Ohio, United States, 43952
        • Regional Cardiac Arrhythmia, Inc
      • Westerville, Ohio, United States, 43801
        • Mount Carmel Columbus Cardiology Consultants
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital Pocono
      • Bryn Mawr, Pennsylvania, United States, 19146
        • Bryn Mawr Medical Specialists
      • Newtown, Pennsylvania, United States, 18940
        • The Arrhythmia Institute
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian University of Pennsylvania Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Trident Medical Center
      • Florence, South Carolina, United States, 29506
        • McLeod Cardiology Associates
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Rapid City Hospital, Inc.
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System in Dallas
      • Fort Worth, Texas, United States, 76104
        • Apex Trials Group, LLC
      • Houston, Texas, United States, 77030
        • University of Texas Houston Health Science Center
      • Lufkin, Texas, United States, 75904
        • Heart Institute of East Texas
      • New Braunfels, Texas, United States, 78130
        • Mission Research Institute
    • Utah
      • Ogden, Utah, United States, 84403
        • McKay Dee Cardiology
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospitals and Clinics
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health System
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Heart & Vascular Institute
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23225
        • Virginia Cardiovascular Specialist
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Centre Everett
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54305
        • Bellin Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 60 days post implant up to five years

Secondary Outcome Measures

Outcome Measure
Time Frame
• All-cause mortality
Time Frame: From 60 days post implant up to five years
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
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
From 60 days post implant up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2016

Primary Completion (Actual)

July 6, 2023

Study Completion (Actual)

July 6, 2023

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimated)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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