Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2012-05-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Control Group
Historical control HeartMate II BTT and DT data
No interventions assigned to this group
Prospective and Retrospectively identified SSI
Prospectively and Retrospectively identified HeartMate II patients where the full length of the velour coated portion of the driveline is tunneled under the skin
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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David Farrar, PhD
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St.Vincent's Hospital and Health Services
Indianapolis, Indiana, United States
University of Iowa Hospital
Iowa City, Iowa, United States
Henry Ford Hospital
Detroit, Michigan, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Baylor Medical Center
Dallas, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Countries
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References
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Akhter SA, Ewald GA, Walsh MN, et al. Preliminary driveline infection results from the multicenter silicone-skin-interface (SSI) registry. Abstracts from the ASAIO 59th Annual Conference, p. 61. http://journals.lww.com/asaiojournal/Documents/ASAIO%20Abstracts%202013.pdf
Other Identifiers
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TC11282011
Identifier Type: -
Identifier Source: org_study_id
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