LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
NCT ID: NCT02091011
Last Updated: 2022-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1600 participants
OBSERVATIONAL
2014-01-27
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort group
Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an Institution's Institutional Review Board (IRB), Research Ethics Board (REB) or Ethics Committee (EC)
* Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study.
Exclusion Criteria
* Subject is under the legal age for signing study consent in accordance with state or national law
* Subject has a life expectancy of less than twelve months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician's discretion)
* Subject on active heart transplant list
* Subject with any prior pulse generator infection or lead infection which is either systemic or localized
* Subject received a commercially available Boston Scientific ICD or CRT-D device with a battery capacity of 1.5 amp/hour or less
* Subject implanted with Boston Scientific's subcutaneous implantable defibrillator system (s-ICD) or has a lead that is under recall/advisory at the time of enrollment
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Samir Saba, MD, FACC, FHRS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Locations
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Alabama cardiovascular group
Birmingham, Alabama, United States
Birmingham Heart Clinic, P.C.
Birmingham, Alabama, United States
Phoenix Heart, PLLC
Glendale, Arizona, United States
Pima Heart Physicians PC
Tucson, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Mercy Clinic Cardiology Physician Plaza
Rogers, Arkansas, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
Jackson Memorial Hospital, JHS Office of Research
Miami, Florida, United States
Florida Electrophysiology, LLC
Orlando, Florida, United States
Bay Area Heart Center
St. Petersburg, Florida, United States
Alexian Brothers
Elk Grove Village, Illinois, United States
Franciscan Physician Network Cardiology Crown Point
Crown Point, Indiana, United States
The Heart Group, PC
Newburgh, Indiana, United States
InityPoint Health - St. Luke's Hospital
Cedar Rapids, Iowa, United States
Advance Cardiovascular Specialists
Shreveport, Louisiana, United States
Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, United States
Mass Heart and Rhythm
Leominster, Massachusetts, United States
McLaren Bay
Bay City, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Great Lakes Heart And Vascular Institute
Saint Joseph, Michigan, United States
Cardiovascular Clinic of Hattiesburg
Hattiesburg, Mississippi, United States
Wesley Medical Center
Hattiesburg, Mississippi, United States
Kansas City Heart Foundation
Kansas City, Missouri, United States
PCRMC Medical Group
Rolla, Missouri, United States
Gateway Cardiology
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
University Hospital, Newark
Newark, New Jersey, United States
Stony Brook Community Medical, PC
East Setauket, New York, United States
New York Hospital Queens
Flushing, New York, United States
Westchester Heart & Vascular
Hawthorne, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
Stark Medical Specialties
Massillon, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oregon Cardiology Sacred Heart at Riverbend Hospital
Springfield, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Heart and Vascular Institute, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Carolina Cardiology Assoc, Piedmont Medical Center
Rock Hill, South Carolina, United States
Parkridge Medical Ctr.
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Heart Rhythm
Houston, Texas, United States
Cardiology Clinic San Antonio
San Antonio, Texas, United States
Central Utah Clinic
Provo, Utah, United States
Cardiology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Carient Heart & Vasculare
Manassas, Virginia, United States
CAMC Health Education and Research Institute
Charleston, West Virginia, United States
Prevea Clinic, Inc.
Green Bay, Wisconsin, United States
Clinical Research Specialist, Research Institute ProHealth Care, Inc
Waukesha, Wisconsin, United States
Cardiology Research Group Royal Alexandra Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Hospital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, CHUS/CRC
Sherbrooke, Quebec, Canada
Charite Campus Virchow Klinikum
Berlin, , Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Kardiologie und Angiologie
Kiel, , Germany
Chiba University Hospital
Chiba, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
Japan Labour Health and and Welfare Organization, Yokohama Rosai Hospital
Kanagawa-Prefecture, , Japan
Saitama Medical University, Saitama Redcross Hospital
Saitama, , Japan
Tokohu University Hospital
Sendai, , Japan
Showa University Hospital
Tokyo, , Japan
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary Hospital
Seoul, , South Korea
Sejong General Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Hospital Universitario de Cruces. Servicio de Cardiología
Barakaldo, , Spain
Hospital Universitario La Paz. Servicio de Cardiología. Sección de Arritmias. Planta primera diagonal
Madrid, , Spain
Hospital Universitario "Miguel Servet". Servicio de Cardiología
Zaragoza, , Spain
Universitatsspital Basel Klinik fur Kardiologie
Basel, , Switzerland
Kantonspital St Gallen, Klinik fur Kardiologie
Sankt Gallen, , Switzerland
Bristol Heart Institute
Bristol, , United Kingdom
St Bartholomew's Hospital, EP Cardiac Research Department, Barts Health NHS Trust
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
University Hospital of Southhampton
Southampton, , United Kingdom
Countries
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Other Identifiers
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PDM 90912475
Identifier Type: -
Identifier Source: org_study_id
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