LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
- Conditions
- CRT-D Cardiac Resynchronization Therapy DefibrillatorImplantable Cardioverter Defibrillators
- Registration Number
- NCT02091011
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
- Subject has been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device according to current guidelines and/or center's current practice
- 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.
- Subject is unable or unwilling to comply with the study protocol requirements
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the rate and cause of all-cause device replacements of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation. 5 years Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation. 5 years Battery survival is defined as freedom from surgical replacement of the device due to battery depletion.
- Secondary Outcome Measures
Name Time Method Determine the rate and cause of all-cause device replacement of Boston Scientific's market-released ICD and CRT-D devices 1, 2, 3 and 4 years post-implantation. 1, 2, 3, and 4 years Evaluate battery survival of Boston Scientific's market-released ICD and CRT-D devices at 1, 2, 3 and 4 years post-implantation. 1, 2, 3, and 4 years Evaluate the device survival of Boston Scientific's market released ICD and CRT-D pulse generators at 5 years post-implantation; and compare it to the survival probability presented in the Product Performance Report (PPR). 5 years Evaluate potential predictors of device battery longevity at 5 years post-implantation. 5 years
Trial Locations
- Locations (80)
VA Loma Linda Healthcare System
🇺🇸Loma Linda, California, United States
Wesley Medical Center
🇺🇸Hattiesburg, Mississippi, United States
University Hospital, Newark
🇺🇸Newark, New Jersey, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
Parkridge Medical Ctr.
🇺🇸Chattanooga, Tennessee, United States
Heart and Vascular Institute, University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
CAMC Health Education and Research Institute
🇺🇸Charleston, West Virginia, United States
Clinical Research Specialist, Research Institute ProHealth Care, Inc
🇺🇸Waukesha, Wisconsin, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Gateway Cardiology
🇺🇸Saint Louis, Missouri, United States
Cardiology Associates of Fredericksburg
🇺🇸Fredericksburg, Virginia, United States
Cardiology Research Group Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Jackson Memorial Hospital, JHS Office of Research
🇺🇸Miami, Florida, 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
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Pima Heart Physicians PC
🇺🇸Tucson, Arizona, United States
Alabama cardiovascular group
🇺🇸Birmingham, Alabama, United States
Birmingham Heart Clinic, P.C.
🇺🇸Birmingham, Alabama, United States
Phoenix Heart, PLLC
🇺🇸Glendale, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Mercy Clinic Cardiology Physician Plaza
🇺🇸Rogers, Arkansas, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Bradenton Cardiology Center
🇺🇸Bradenton, Florida, United States
Alexian Brothers
🇺🇸Elk Grove Village, Illinois, United States
Bay Area Heart Center
🇺🇸Saint Petersburg, Florida, 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
Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc.
🇺🇸Salisbury, Maryland, United States
Advance Cardiovascular Specialists
🇺🇸Shreveport, Louisiana, United States
Mass Heart and Rhythm
🇺🇸Leominster, Massachusetts, United States
McLaren Bay
🇺🇸Bay City, Michigan, United States
Great Lakes Heart And Vascular Institute
🇺🇸Saint Joseph, Michigan, United States
Cardiovascular Clinic of Hattiesburg
🇺🇸Hattiesburg, Mississippi, United States
Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
PCRMC Medical Group
🇺🇸Rolla, Missouri, United States
St. Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
Stony Brook Community Medical, PC
🇺🇸East Setauket, New York, United States
Westchester Heart & Vascular
🇺🇸Hawthorne, New York, United States
New York Hospital Queens
🇺🇸Flushing, New York, United States
Stark Medical Specialties
🇺🇸Massillon, Ohio, United States
Oregon Cardiology Sacred Heart at Riverbend Hospital
🇺🇸Springfield, Oregon, United States
Carolina Cardiology Assoc, Piedmont Medical Center
🇺🇸Rock Hill, South Carolina, United States
Carient Heart & Vasculare
🇺🇸Manassas, Virginia, United States
Central Utah Clinic
🇺🇸Provo, Utah, United States
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Charite Campus Virchow Klinikum
🇩🇪Berlin, Germany
Hospital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
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
Tokohu University Hospital
🇯🇵Sendai, Japan
Saitama Medical University, Saitama Redcross Hospital
🇯🇵Saitama, Japan
Showa University Hospital
🇯🇵Tokyo, Japan
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Universitario de Cruces. Servicio de Cardiología
🇪🇸Barakaldo, Spain
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Hospital Universitario "Miguel Servet". Servicio de Cardiología
🇪🇸Zaragoza, Spain
Bristol Heart Institute
🇬🇧Bristol, United Kingdom
Kantonspital St Gallen, Klinik fur Kardiologie
🇨🇭St. Gallen, Switzerland
St Bartholomew's Hospital, EP Cardiac Research Department, Barts Health NHS Trust
🇬🇧London, United Kingdom
University Hospital of Southhampton
🇬🇧Southampton, United Kingdom
Hospital Universitario La Paz. Servicio de Cardiología. Sección de Arritmias. Planta primera diagonal
🇪🇸Madrid, Spain
Prevea Clinic, Inc.
🇺🇸Green Bay, Wisconsin, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Sejong General Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
Florida Electrophysiology, LLC
🇺🇸Orlando, Florida, United States
Kansas City Heart Foundation
🇺🇸Kansas City, Missouri, United States
Centre Hospitalier Universitaire de Sherbrooke, CHUS/CRC
🇨🇦Sherbrooke, Quebec, Canada
Universitatsspital Basel Klinik fur Kardiologie
🇨🇭Basel, Switzerland
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States