Thoratec's Reduce Driveline Trauma Through Stabilization... | NCT01485666

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

NCT01485666

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Jun 24, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Left Ventricular Assist Device
Percutaneous Lead Management

Interventions

Percutaneous Lead Management Kit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Dec 1, 2011

First Submission Date that Met QC Criteria

Dec 2, 2011

First Posted Date

Dec 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2022

Last Update Posted Date

Jun 24, 2022Actual

Name	Class
Thoratec Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous Lead Management Kit	Other	A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization		Thoratec HeartMate II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit		Up to 30 days

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Ventricular Assist Device clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pooja Chatterjee	Thoratec Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Sharp Memorial Hospital