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

Left Ventricular Assist Device Clinical Trial

— RESIST  

Official title:

Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485666
• Other study ID #: TC06072011-1
• Status: Completed
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Assist Device
• Percutaneous Lead Management

Intervention

Other:
• Percutaneous Lead Management Kit
A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Rochester Medical Center	Rochester	New York
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of the wearability and usability of the Percutaneous Lead Management Kit		Up to 30 days
Secondary	Incidence of adverse reactions to any Percutaneous Lead Management Kit components		Up to 6 months
Secondary	Evidence of driveline infection		Up to 6 months
Secondary	Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization		Up to 7 days continuous kit use