Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
NCT ID: NCT01485666
Last Updated: 2022-06-24
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
50 participants
OBSERVATIONAL
2012-05-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Percutaneous Lead Management Kit
A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 16 years of age or older
* Supported by HeartMate II LVAD continuously for at least 6 months and not currently hospitalized
* Will continue on LVAD support for at least another 30 days
* No driveline or systemic infection
* Willing and able to perform kit dressing changes at least once every 7 days for 30 days
* Can fill out study forms
* Can use a digital camera
* Willing to return to clinic for final study visit in 30 days
Exclusion Criteria
* Ongoing mechanical circulatory support other than HeartMate II LVAD
* Sensitivity to kit components
* Skin condition that may react to kit component adhesives
* Already using all components of Percutaneous Lead Management Kit
16 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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Pooja Chatterjee
Role: STUDY_DIRECTOR
Thoratec Corporation
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Sharp Memorial Hospital
San Diego, California, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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TC06072011-1
Identifier Type: -
Identifier Source: org_study_id
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