Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 5:10 AM
Study NCT ID:
NCT01485666
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2011-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESIST
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: