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

Abbott Medical Devices50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Left Ventricular Assist Device Percutaneous Lead Management

Interventions

Percutaneous Lead Management KitOTHER

A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Demonstration of the wearability and usability of the Percutaneous Lead Management Kit

Time frame: Up to 30 days

Secondary Outcomes

Incidence of adverse reactions to any Percutaneous Lead Management Kit components

Time frame: Up to 6 months

Evidence of driveline infection

Time frame: Up to 6 months

Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization

Time frame: Up to 7 days continuous kit use

Data from ClinicalTrials.gov

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