LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 9/20/2018 |
Start Date: | January 27, 2014 |
End Date: | June 1, 2021 |
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices.
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)
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)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
52
sites
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Pittsburgh, Pennsylvania 15213
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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