Driveline Silicone Skin Interface Registry



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:May 2012
End Date:December 2018

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Driveline Silicone Skin Interface (SSI) Registry

The purpose of this observational registry is to determine the freedom from driveline (DL)
infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone
portion of the DL is externalized resulting in a silicone skin interface (SSI)


Inclusion Criteria:

- Subject has signed the INTERMACS informed consent form

- Subject has signed the SSI registry informed consent form

- Subject age ≥ 18 years

- Subject implanted with a HeartMate II LVAD

- Subject in whom the full length of the velour portion of the percutaneous lead is
fully kept under the skin resulting in a silicone skin interface at the skin exit site

- In the prospective study cohort, Subject is planned to be supported with the HeartMate
II LVAD for at least 12 months

- In the retrospective study cohort, at the time of enrollment, Subject has been
supported with a HeartMate II for at least 10 months

Exclusion Criteria:

- In the retrospective study cohort, Subject is ongoing with long-term right heart
mechanical circulatory support (RVAD)

- In the retrospective study cohort, Subject had a post-implant sternal re-entry (for
bleeding, etc.) or delayed sternal closure

- In the retrospective study cohort, Subject is participating in any other clinical
investigation related to driveline (DL) exit site that could confound the study
results

- In the prospective study cohort, Subject is participating in any other clinical
investigation related to driveline (DL) exit site that could confound the study
results
We found this trial at
15
sites
Atlanta, Georgia 30309
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Atlanta, GA
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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Dallas, Texas 75226
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Dallas, TX
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Iowa City, Iowa 52242
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Iowa City, IA
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oak Lawn, IL
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Spokane, Washington 99204
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Spokane, WA
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