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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01485666
Other study ID # TC06072011-1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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