Left Ventricular Assist Device, Percutaneous Lead Management
Conditions
Keywords
Thoratec, HeartMate II, heart-assist devices, driveline or percutaneous lead management, HeartMate II Percutaneous Lead Management
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.
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.
Interventions
OTHERPercutaneous Lead Management Kit
A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization
Sponsors
Thoratec Corporation
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstration of the wearability and usability of the Percutaneous Lead Management Kit | Up to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed