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

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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)


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
3322 West End Avenue
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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931 S. 9th Street
Bismarck, North Dakota 58504
701-530-6954
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Bismarck, ND
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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Flint, MI
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1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
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Kalamazoo, MI
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Asheville, North Carolina 28801
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1900 Columbus Avenue
Bay City, Michigan 48708
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Birmingham, Alabama 35205
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Birmingham, Alabama 35235
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Bradenton, Florida 34208
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Cedar Rapids, Iowa 53402
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Charleston, West Virginia 25304
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Chattanooga, Tennessee 37404
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Crown Point, Indiana 46307
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East Setauket, New York 11733
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Edmonton,
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Elk Grove Village, Illinois 60007
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Flushing, New York 11355
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Fredericksburg, Virginia 22408
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Glendale, Arizona 85306
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Green Bay, Wisconsin 54303
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Hattiesburg, Mississippi 39402
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Hattiesburg, Mississippi 39402
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Houston, Texas 77074
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Kansas City, Missouri 64132
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Leominster, Massachusetts 01453
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Loma Linda, California 92357
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Manassas, Virginia 20109
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Massillon, Ohio 44646
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Miami, Florida 33176
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Newark, New Jersey 07103
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Newburgh, Indiana 47630
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Oklahoma City, Oklahoma
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14501 Gatorland Drive
Orlando, Florida 32837
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Provo, Utah 84604
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Rock Hill, South Carolina 29732
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Rolla, Missouri 65401
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Saint Louis, Missouri 63128
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Saint Louis, Missouri 63136
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Saint Petersburg, Florida 33709
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Salisbury, Maryland 21804
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San Antonio, Texas 78229
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Shreveport, Louisiana 71105
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Tucson, Arizona 85712
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Valhalla, New York 10595
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110 Irving St NW
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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Waukesha, Wisconsin 53188
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