Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study (RESIST)

Abbott

Status: Completed

Conditions: Percutaneous Lead Management; Left Ventricular Assist Device

Treatments: Other: Percutaneous Lead Management Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT01485666

TC06072011-1

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 50 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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