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

Completed

• Conditions: Left Ventricular Assist Device; Percutaneous Lead Management

• Registration Number: NCT01485666
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Study Start: 2012-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit	Up to 30 days

Secondary Outcome Measures

Name	Time	Method
Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization	Up to 7 days continuous kit use
Incidence of adverse reactions to any Percutaneous Lead Management Kit components	Up to 6 months
Evidence of driveline infection	Up to 6 months

Trial Locations

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

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States