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

NCT01485666 | Completed

• 1 other identifier: TC06072011-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Left Ventricular Assist Device; Percutaneous Lead Management

Keywords

Thoratec; HeartMate II; heart-assist devices; driveline or percutaneous lead management; HeartMate II Percutaneous Lead Management

Outcome Measures

Primary Outcomes (1)

• Demonstration of the wearability and usability of the Percutaneous Lead Management Kit

  Up to 30 days

Secondary Outcomes (3)

• 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

Interventions

Percutaneous Lead Management Kit OTHER

A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization

Also known as: Thoratec, HeartMate II

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ventricular Assist Device clinic

You may qualify if:

• Signed informed consent form
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Corporation: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Pooja Chatterjee

  Thoratec Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

US (5)