Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
APPRAISE ATP
1 other identifier
interventional
2,692
8 countries
134
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2023
CompletedResults Posted
Study results publicly available
October 22, 2024
CompletedOctober 22, 2024
September 1, 2024
6.8 years
October 3, 2016
July 1, 2024
September 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-Cause Shock
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.
5 years
Secondary Outcomes (4)
All-Cause Shock or Death From Any Cause
5 years
Appropriate Shock
5 years
Inappropriate Shock
5 years
All Cause Mortality
5 years
Study Arms (2)
ATP and Shock
ACTIVE COMPARATOROnce tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
Shock only
EXPERIMENTALOnce tachycardia has been detected and duration met, this group would receive shock therapy only.
Interventions
Subjects will be randomized and device programmed to the respective arm.
Subjects will be randomized and device programmed to the respective arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Tri-City Cardiology
Mesa, Arizona, 85206, United States
Cardiovascular Consultants, LTD
Phoenix, Arizona, 85032, United States
Yuma Regional Medical Center
Yuma, Arizona, 85364, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Mercy Clinic Cardiology
Rogers, Arkansas, 72758, United States
Comprehensive Cardiovascular Specialists
Alhambra, California, 91801, United States
Scripps Mercy Chula Vista
Chula Vista, California, 91910, United States
VA Loma Linda
Loma Linda, California, 92357, United States
Cardiovascular Consultants Medical Group
Los Angeles, California, 90024, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
Cardiac Specialists
Danbury, Connecticut, 06810, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
Christiana Hospital
Newark, Delaware, 19805, United States
Bradenton Cardiology
Bradenton, Florida, 34205, United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605, United States
St Vincent's Medical Center
Jacksonville, Florida, 32204, United States
Heart of the Villages
Lady Lake, Florida, 32159, United States
Watson Clinic Center for Research, Inc
Lakeland, Florida, 33805, United States
Charlotte Heart & Vascular
Port Charlotte, Florida, 33952, United States
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida, 32955, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
AdventHeatlh Tampa
Tampa, Florida, 33624, United States
CorVita Science Foundation
Chicago, Illinois, 60605, United States
Adventist Hinsdale Hospital
Chicago, Illinois, 60612, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Lutheran Medical Group
Fort Wayne, Indiana, 46804, United States
Ball Memorial Hospital
Muncie, Indiana, 47303, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, 50266, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Louisiana State University
Shreveport, Louisiana, 71103, United States
Union Memorial Hospital
Baltimore, Maryland, 21237, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Richard A. Henson Research Institute of Peninsula Regional Medical Center
Salisbury, Maryland, 21804, United States
Lahey Clinic Hospital
Burlington, Massachusetts, 01805, United States
Southcoast Physicians Group
Fall River, Massachusetts, 02720, United States
Mass Heart and Rhythm
Leominster, Massachusetts, 01453, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Cardiology Consultants of East Michigan
Flint, Michigan, 48532, United States
Western Michigan University - Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49048, United States
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
St. Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Heart and Vascular Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Cox Health
Springfield, Missouri, 65807, United States
The Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Cardiovascular Associates of the Delaware Valley.
Haddon Heights, New Jersey, 08035, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
St. Joseph's Region Medical Center
Paterson, New Jersey, 07503, United States
Weill Cornell Medical University
New York, New York, 10021, United States
Memorial Mission Hospital
Asheville, North Carolina, 28803, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Regional Cardiac Arrhythmia, Inc
Steubenville, Ohio, 43952, United States
Mount Carmel Columbus Cardiology Consultants
Westerville, Ohio, 43801, United States
Lehigh Valley Hospital Pocono
Allentown, Pennsylvania, 18103, United States
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, 19146, United States
The Arrhythmia Institute
Newtown, Pennsylvania, 18940, United States
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Trident Medical Center
Charleston, South Carolina, 29406, United States
McLeod Cardiology Associates
Florence, South Carolina, 29506, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, 57701, United States
VA North Texas Health Care System in Dallas
Dallas, Texas, 75216, United States
Apex Trials Group, LLC
Fort Worth, Texas, 76104, United States
University of Texas Houston Health Science Center
Houston, Texas, 77030, United States
Heart Institute of East Texas
Lufkin, Texas, 75904, United States
Mission Research Institute
New Braunfels, Texas, 78130, United States
McKay Dee Cardiology
Ogden, Utah, 84403, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132, United States
VA Salt Lake City Health System
Salt Lake City, Utah, 84148, United States
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia, 23116, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Cardiovascular Specialist
Richmond, Virginia, 23225, United States
Providence Regional Medical Centre Everett
Everett, Washington, 98201, United States
PeaceHealth Southwest Medical
Vancouver, Washington, 98664, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Bellin Health
Green Bay, Wisconsin, 54305, United States
Kepler Universitaetsklinikum GmbH
Linz, 4021, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W4, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, V8T 1Z4, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Scarborough Health Network-Centenary Site
Scarborough Village, Ontario, M1B 4Z8, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W 1T8, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec.
Québec, Quebec, G1V 4G5, Canada
Policlinico di Modena
Modena, Emilia-Romagna, 41124, Italy
Osp. Civile S. Maria Delle Grazie
Pozzuoli, Southern Cluster, 80018, Italy
Presidio Ospedale San Giovanni Bosco
Napoli, 80100, Italy
Hospital Buon Consiglio
Napoli, 80123, Italy
Ospedale dei Pellegrini
Napoli, 8133, Italy
Az. Osp. S. Andrea
Rome, 00189, Italy
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
Kokura Memorial Hospital
Kitakyushu-Shi, Fukuoka, 802-8555, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Kyoto University Hospital
Kyoto, Kyoto-shi,, 606-8507, Japan
Tachikawa General Hospital
Nagaoka-shi, Niigata, 940-8621, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
National Crebral and Cardiovascular Center Hospital
Suita, Osaka, 565-8565, Japan
Saitama Medical University International Medical Cnter
Hidaka-shi, Saitama, 350-1298, Japan
Chonnam National University
Gwangju, Donggu, 501-757, South Korea
Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
Sejong General Hospital
Bucheon-si, Gyeonggi-do, 14754, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsang, 50612,, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 120-752, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Donostia
San Sebastián, 20014, Spain
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Liverpool Heart and Chest - LHCH
Liverpool, L14 3PE, United Kingdom
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Related Publications (1)
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.
PMID: 39361311DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
COVID-19 led to an increase in missed visits, late visits, withdrawals and several site personnel changes. Additional ATP programming options were not evaluated, only the effect of a single ATP burst of 8 pulses at 88% cycle length. The differential delay to shock between arms due to ATP (\~3 seconds) may have led to more shocks in the Shock Only arm. The utility of ATP in other primary prevention indications was not assessed.
Results Point of Contact
- Title
- Jacqueline Beaulieu, Sr. Clinical Trial Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Schuger, M.D.
University of Rochester Clincal Cardiovascular Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 5, 2016
Study Start
September 30, 2016
Primary Completion
July 6, 2023
Study Completion
July 6, 2023
Last Updated
October 22, 2024
Results First Posted
October 22, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share