Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
NCT ID: NCT02923726
Last Updated: 2024-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2692 participants
INTERVENTIONAL
2016-09-30
2023-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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ATP and Shock
Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
Arm 1 (ATP+Shock)
Subjects will be randomized and device programmed to the respective arm.
Shock only
Once tachycardia has been detected and duration met, this group would receive shock therapy only.
Arm 2 (shock only)
Subjects will be randomized and device programmed to the respective arm.
Interventions
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Arm 1 (ATP+Shock)
Subjects will be randomized and device programmed to the respective arm.
Arm 2 (shock only)
Subjects will be randomized and device programmed to the respective arm.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Claudio Schuger, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Clincal Cardiovascular Research Center
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Tri-City Cardiology
Mesa, Arizona, United States
Cardiovascular Consultants, LTD
Phoenix, Arizona, United States
Yuma Regional Medical Center
Yuma, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Mercy Clinic Cardiology
Rogers, Arkansas, United States
Comprehensive Cardiovascular Specialists
Alhambra, California, United States
Scripps Mercy Chula Vista
Chula Vista, California, United States
VA Loma Linda
Loma Linda, California, United States
Cardiovascular Consultants Medical Group
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Cardiac Specialists
Danbury, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Bradenton Cardiology
Bradenton, Florida, United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States
St Vincent's Medical Center
Jacksonville, Florida, United States
Heart of the Villages
Lady Lake, Florida, United States
Watson Clinic Center for Research, Inc
Lakeland, Florida, United States
Charlotte Heart & Vascular
Port Charlotte, Florida, United States
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
AdventHeatlh Tampa
Tampa, Florida, United States
CorVita Science Foundation
Chicago, Illinois, United States
Adventist Hinsdale Hospital
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
Ball Memorial Hospital
Muncie, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Louisiana State University
Shreveport, Louisiana, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Richard A. Henson Research Institute of Peninsula Regional Medical Center
Salisbury, Maryland, United States
Lahey Clinic Hospital
Burlington, Massachusetts, United States
Southcoast Physicians Group
Fall River, Massachusetts, United States
Mass Heart and Rhythm
Leominster, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cardiology Consultants of East Michigan
Flint, Michigan, United States
Western Michigan University - Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, United States
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
St. Luke's Hospital of Duluth
Duluth, Minnesota, United States
Heart and Vascular Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Cox Health
Springfield, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cardiovascular Associates of the Delaware Valley.
Haddon Heights, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
St. Joseph's Region Medical Center
Paterson, New Jersey, United States
Weill Cornell Medical University
New York, New York, United States
Memorial Mission Hospital
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Regional Cardiac Arrhythmia, Inc
Steubenville, Ohio, United States
Mount Carmel Columbus Cardiology Consultants
Westerville, Ohio, United States
Lehigh Valley Hospital Pocono
Allentown, Pennsylvania, United States
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, United States
The Arrhythmia Institute
Newtown, Pennsylvania, United States
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Trident Medical Center
Charleston, South Carolina, United States
McLeod Cardiology Associates
Florence, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, United States
VA North Texas Health Care System in Dallas
Dallas, Texas, United States
Apex Trials Group, LLC
Fort Worth, Texas, United States
University of Texas Houston Health Science Center
Houston, Texas, United States
Heart Institute of East Texas
Lufkin, Texas, United States
Mission Research Institute
New Braunfels, Texas, United States
McKay Dee Cardiology
Ogden, Utah, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
VA Salt Lake City Health System
Salt Lake City, Utah, United States
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Cardiovascular Specialist
Richmond, Virginia, United States
Providence Regional Medical Centre Everett
Everett, Washington, United States
PeaceHealth Southwest Medical
Vancouver, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Bellin Health
Green Bay, Wisconsin, United States
Kepler Universitaetsklinikum GmbH
Linz, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Scarborough Health Network-Centenary Site
Scarborough Village, Ontario, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec.
Québec, Quebec, Canada
Policlinico di Modena
Modena, Emilia-Romagna, Italy
Osp. Civile S. Maria Delle Grazie
Pozzuoli, Southern Cluster, Italy
Presidio Ospedale San Giovanni Bosco
Napoli, , Italy
Hospital Buon Consiglio
Napoli, , Italy
Ospedale dei Pellegrini
Napoli, , Italy
Az. Osp. S. Andrea
Rome, , Italy
Chiba University Hospital
Chiba, Chiba, Japan
Kokura Memorial Hospital
Kitakyushu-Shi, Fukuoka, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Kyoto University Hospital
Kyoto, Kyoto-shi,, Japan
Tachikawa General Hospital
Nagaoka-shi, Niigata, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
National Crebral and Cardiovascular Center Hospital
Suita, Osaka, Japan
Saitama Medical University International Medical Cnter
Hidaka-shi, Saitama, Japan
Chonnam National University
Gwangju, Donggu, South Korea
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Sejong General Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsang, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Donostia
San Sebastián, , Spain
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Liverpool Heart and Chest - LHCH
Liverpool, , United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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References
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Schuger C, Joung B, Ando K, Mont L, Lambiase PD, O'Hara GE, Jennings JM, Yung D, Boriani G, Piccini JP, Wold N, Stein KM, Daubert JP; APPRAISE ATP Investigators. Assessment of Antitachycardia Pacing in Primary Prevention Patients: The APPRAISE ATP Randomized Clinical Trial. JAMA. 2024 Nov 26;332(20):1723-1731. doi: 10.1001/jama.2024.16531.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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C1924
Identifier Type: -
Identifier Source: org_study_id
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