Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study (RESIST)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Left Ventricular Assist DevicePercutaneous Lead Management
Other: Percutaneous Lead Management Kit
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 stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ventricular Assist Device clinic
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
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