Status:
COMPLETED
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Corporation
Conditions:
Left Ventricular Assist Device
Percutaneous Lead Management
Eligibility:
All Genders
16+ years
Brief Summary
The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.
Detailed Description
The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and st...
Eligibility Criteria
Inclusion
- Signed informed consent form
- 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
- High risk for non-compliance
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01485666
Start Date
May 1 2012
End Date
August 1 2013
Last Update
June 24 2022
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
3
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
4
University of Rochester Medical Center
Rochester, New York, United States, 14642