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)
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, District of Columbia, United States
Bradenton Cardiology Center
🇺🇸Bradenton, Florida, United States
Jackson Memorial Hospital, JHS Office of Research
🇺🇸Miami, Florida, United States
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