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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01485666
First received: December 1, 2011
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention
Left Ventricular Assist Device
Percutaneous Lead Management
Other: Percutaneous Lead Management Kit

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol

Resource links provided by NLM:


Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Demonstration of the wearability and usability of the Percutaneous Lead Management Kit [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse reactions to any Percutaneous Lead Management Kit components [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Evidence of driveline infection [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization [ Time Frame: Up to 7 days continuous kit use ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Percutaneous Lead Management Kit
    A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization
    Other Names:
    • Thoratec
    • HeartMate II
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Ventricular Assist Device clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485666

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Thoratec Corporation
  More Information

No publications provided

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01485666     History of Changes
Other Study ID Numbers: TC06072011-1
Study First Received: December 1, 2011
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Thoratec Corporation:
Thoratec
HeartMate II
heart-assist devices
driveline or percutaneous lead management
HeartMate II Percutaneous Lead Management

ClinicalTrials.gov processed this record on July 26, 2014