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

June 23, 2022 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Ventricular Assist Device clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit
Time Frame: Up to 30 days
Up to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TC06072011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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