NCT01485666

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Ventricular Assist Device
• Percutaneous Lead Management

Interventions

Type	Name	Description
OTHER	Percutaneous Lead Management Kit	A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-12-05
• Last updated: 2022-06-24

Locations

5 sites across 1 country: United States