Left Ventricular Assist Device Clinical Trial
— RESISTOfficial title:
Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
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 |
Verified date | June 2022 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices | Thoratec Corporation |
United States,
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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