Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
Status: Completed
Location: See all (134) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
Alaska
Providence Alaska Medical Center
Anchorage
Alabama
Heart Center Research, LLC
Huntsville
Arkansas
Arrhythmia Research Group
Jonesboro
Mercy Clinic Cardiology
Rogers
Arizona
Tri-City Cardiology
Mesa
Cardiovascular Consultants, LTD
Phoenix
Yuma Regional Medical Center
Yuma
California
Comprehensive Cardiovascular Specialists
Alhambra
Scripps Mercy Chula Vista
Chula Vista
VA Loma Linda
Loma Linda
Cardiovascular Consultants Medical Group
Los Angeles
Sharp Memorial Hospital
San Diego
Colorado
South Denver Cardiology Associates PC
Littleton
Connecticut
Cardiac Specialists
Danbury
Stamford Hospital
Stamford
Delaware
Christiana Hospital
Newark
Florida
Bradenton Cardiology
Bradenton
The Cardiac and Vascular Institute Research Foundation
Gainesville
St Vincent's Medical Center
Jacksonville
Heart of the Villages
Lady Lake
Watson Clinic Center for Research, Inc
Lakeland
Charlotte Heart & Vascular
Port Charlotte
Brevard Cardiovascular Research Associates, Inc
Rockledge
Tallahassee Memorial Hospital
Tallahassee
AdventHeatlh Tampa
Tampa
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Mercy Hospital Medical Center
West Des Moines
Illinois
Adventist Hinsdale Hospital
Chicago
CorVita Science Foundation
Chicago
Alexian Brothers Medical Center
Elk Grove Village
Indiana
Lutheran Medical Group
Fort Wayne
Ball Memorial Hospital
Muncie
Kansas
Overland Park Regional Medical Center
Overland Park
Kentucky
Baptist Health Lexington
Lexington
Louisiana
Louisiana State University
Shreveport
Massachusetts
Lahey Clinic Hospital
Burlington
Southcoast Physicians Group
Fall River
Mass Heart and Rhythm
Leominster
University of Massachusetts Memorial Medical Center
Worcester
Maryland
Johns Hopkins Hospital
Baltimore
Union Memorial Hospital
Baltimore
Richard A. Henson Research Institute of Peninsula Regional Medical Center
Salisbury
Michigan
Henry Ford Hospital
Detroit
Cardiology Consultants of East Michigan
Flint
Western Michigan University - Homer Stryker M.D. School of Medicine
Kalamazoo
Great Lakes Heart & Vascular Institute
Saint Joseph
Munson Medical Center
Traverse City
Metro Health Hospital
Wyoming
St. Joseph Mercy Hospital
Ypsilanti
Minnesota
St. Luke's Hospital of Duluth
Duluth
Missouri
Cox Health
Springfield
Mississippi
Heart and Vascular Hattiesburg Clinic
Hattiesburg
North Carolina
Memorial Mission Hospital
Asheville
Duke University Medical Center
Durham
Wake Forest University School of Medicine
Winston-salem
Nebraska
The Nebraska Medical Center
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New Jersey
Cardiovascular Associates of the Delaware Valley.
Haddon Heights
Jersey Shore University Medical Center
Neptune
St. Joseph's Region Medical Center
Paterson
New York
Weill Cornell Medical University
New York
Ohio
Cleveland Clinic Foundation
Cleveland
Kettering Medical Center
Kettering
Regional Cardiac Arrhythmia, Inc
Steubenville
Mount Carmel Columbus Cardiology Consultants
Westerville
Pennsylvania
Lehigh Valley Hospital Pocono
Allentown
Bryn Mawr Medical Specialists
Bryn Mawr
The Arrhythmia Institute
Newtown
Presbyterian University of Pennsylvania Medical Center
Philadelphia
Temple University Hospital
Philadelphia
South Carolina
Trident Medical Center
Charleston
McLeod Cardiology Associates
Florence
Lexington Medical Center
West Columbia
South Dakota
Monument Health Rapid City Hospital, Inc.
Rapid City
Texas
VA North Texas Health Care System in Dallas
Dallas
Apex Trials Group, LLC
Fort Worth
University of Texas Houston Health Science Center
Houston
Heart Institute of East Texas
Lufkin
Mission Research Institute
New Braunfels
Utah
McKay Dee Cardiology
Ogden
University of Utah Hospitals and Clinics
Salt Lake City
VA Salt Lake City Health System
Salt Lake City
Virginia
Bon Secours Heart & Vascular Institute
Mechanicsville
Sentara Norfolk General Hospital
Norfolk
Virginia Cardiovascular Specialist
Richmond
Washington
Providence Regional Medical Centre Everett
Everett
PeaceHealth Southwest Medical
Vancouver
Wisconsin
Bellin Health
Green Bay
West Virginia
Charleston Area Medical Center
Charleston
Other Locations
Austria
Kepler Universitaetsklinikum GmbH
Linz
Klinikum Wels-Grieskirchen GmbH
Wels
Canada
Royal Alexandra Hospital
Edmonton
Hamilton General Hospital
Hamilton
Centre Hospitalier de l'Universite de Montreal
Montreal
Institut de Cardiologie de Montreal
Montréal
Royal Columbian Hospital
New Westminster
Institut universitaire de Cardiologie et de Pneumologie de Quebec.
Quebec City
Scarborough Health Network-Centenary Site
Scarborough
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria
Italy
Policlinico di Modena
Modena
Hospital Buon Consiglio
Napoli
Ospedale dei Pellegrini
Napoli
Presidio Ospedale San Giovanni Bosco
Napoli
Osp. Civile S. Maria Delle Grazie
Pozzuoli
Az. Osp. S. Andrea
Rome
Japan
Chiba University Hospital
Chiba-shi
Saitama Medical University International Medical Cnter
Hidaka-shi
Kokura Memorial Hospital
Kitakyushu-shi
Kumamoto University Hospital
Kumamoto-shi
Kyoto University Hospital
Kyoto
Tachikawa General Hospital
Nagaoka-shi
Niigata University Medical and Dental Hospital
Niigata-shi
Kitasato University Hospital
Sagamihara-shi
National Crebral and Cardiovascular Center Hospital
Suita
Republic of Korea
Sejong General Hospital
Bucheon-si
Inje University Busan Paik Hospital
Busan
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Chonnam National University
Gwangju
Seoul National University Bundang Hospital
Seongnam-si
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan
Spain
Hospital Clínic de Barcelona
Barcelona
Hospital La Paz
Madrid
Hospital Donostia
San Sebastián
United Kingdom
Royal Bournemouth Hospital
Bournemouth
Liverpool Heart and Chest - LHCH
Liverpool
King's College Hospital
London
St. Bartholomew's Hospital
London
Royal Stoke University Hospital
Stoke-on-trent
Time Frame
Start Date: 2016-09-30
Completion Date: 2023-07-06
Participants
Target number of participants: 2692
Treatments
Active_comparator: ATP and Shock
Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
Experimental: Shock only
Once tachycardia has been detected and duration met, this group would receive shock therapy only.
Authors
Anthony Ochao, Prashant Bhave, Yonathan Melman, Charles Athill, Ghulam M Chaudhry, Kai C Sung, Ihab Girgis, Arnoldas Giedrimas, Rajesh Banker, Robert M Malanuk, Steven J Compton, Sheetal Chandhok, David Lan, Jose Teixeira, Satish Tiyyagura, Charles A Joyner, Rajesh Malik, Vatsal Inamdar, Taral Patel, Darren Sidney, Kevin Kwaku, Daniel B Haithcock, Jeffrey Rothfeld, Adam S Budzikowski, David Meyer, John Jennings, Xiushi Liu, Stephen Keim, Travis S Wall, Eran Zacks, Leenhapong Navaravong, Stephen J Watts, Mohammad Jazayeri, Vivek Bhatia, Arne Sippens-Groenewegen, Sandeep Duggal, Randel Smith, Paul Scott, John Rhyner, John Garner, Jim Cheung, Dwayne Campbell, John V Jayachandran, Brian Jaffe, Steven Rowe, Saumya Sharma, Vijay Chilakamarri, Daniel Buerkel, Paul Gerczuk, Christopher S Stees, Srikanth Sundaram, Michael Rozengarten, Shane Tsai, Phi Wiegn, Maheer Gandhavadi, Timothy Martin, Abdul Alawwa, Charles Love, Brett J Berman, Paari Dominic, Jerome Kuhnlein, Chafik Assal, Yan (Julie) Dong, Kevin Browne, Frank Rubalcava, Rangarao Tummala, Isaac Wiener, Bruce Graham, Craig McCotter, Gad Silberman, Young Hoon Kim, Martin Burke, Jonathan Lowy, Xiaoke Liu, Jeffrey Senfield, Seongwook Han, Christopher Cole, Haseeb Jafri, Robert Winslow, Thomas Hong, Praveer Jain, Chethan Gangireddy, Porur Somasundaram, Kamel Addo, Andrew T Lawrence, Jihn Han, Ronald Lo, Glenn Meininger, Dina Sparano, Andrew Smock, Mihail Chelu, Sergio Cossu, Abhimanyu Beri, Anand Kenia, Maninder Bedi, Jonathan Man, Rohit Kedia, Dionyssios Robotis, Jason Koontz, Piamsook Angkeow, Devi Nair, Stephen Ackerman, Frank Haugland, Sang Weon Park, Evan Lockwood, Raffaele Sangiuolo, Derek Yung, Myung Hwan Bae, Laurence Sterns, Benoit Coutu, Hiroshige Yamabe, Richard Balasubramaniam, Rafael Peinado, Gilles O'Hara, Namsik Yoon, Yong Seog Oh, Hyung Wook Park, Pietro Francia, Daisuke Izumi, Il-Young Oh, Shinichi Niwano, Ashish Patwala, Clemens Steinwender, Paolo Capogrosso, Kenichi Tsujita, Satoshi Shizuta, Blandine Mondesert, Giuseppe Boriani, Youngjin Cho, Pier Lambiase, Jongmin Hwang, Yusuke Kondo, Eue-Keun Choi, Kenji Ando, Kengo Kusano
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation