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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01485666

Collaborator

Thoratec Corporation (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Assist Device Percutaneous Lead Management	Other: Percutaneous Lead Management Kit

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 Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Outcome Measures

Primary Outcome Measures

Demonstration of the wearability and usability of the Percutaneous Lead Management Kit [Up to 30 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Sharp Memorial Hospital	San Diego	California	United States	92123
3	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109
4	University of Rochester Medical Center	Rochester	New York	United States	14642
5	Duke University Medical Center	Durham	North Carolina	United States	27710