Clinical trial NCT01485666: Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
Official title: Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Assist Device
Percutaneous Lead Management
Keywords: Thoratec
HeartMate II
heart-assist devices
driveline or percutaneous lead management
HeartMate II Percutaneous Lead Management
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2011-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ventricular Assist Device clinic

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Demonstration of the wearability and usability of the Percutaneous Lead Management Kit
timeFrame: Up to 30 days
Secondary outcomes:
measure: Incidence of adverse reactions to any Percutaneous Lead Management Kit components
timeFrame: Up to 6 months
measure: Evidence of driveline infection
timeFrame: Up to 6 months
measure: Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization
timeFrame: Up to 7 days continuous kit use
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Thoratec Corporation
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References: