Driveline Silicone Skin Interface Registry (SSI)

This study is currently recruiting participants.

Verified May 2013 by Thoratec Corporation

Sponsor:

Information provided by (Responsible Party):

Thoratec Corporation

ClinicalTrials.gov Identifier:

NCT01577433

First received: April 11, 2012

Last updated: May 14, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 11, 2012

Last Updated Date

May 14, 2013

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

December 2018 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Freedom from DL infection events at 12 months after LVAD implantation [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01577433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of subjects with infection events [ Time Frame: Month 1, 3, 6, and every six months up to 60 months post-enrollment ] [ Designated as safety issue: Yes ]
DL infection events per patient year [ Time Frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment ] [ Designated as safety issue: Yes ]
DL tunneling methods or other factors that might reduce risks of DL related infection events [ Time Frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Driveline Silicone Skin Interface Registry

Official Title ^ICMJE

Driveline Silicone Skin Interface (SSI) Registry

Brief Summary

The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI)

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications

Condition ^ICMJE

Driveline Heart-assisted Device Related Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Control Group
Historical control HeartMate II BTT and DT data
Prospective and Retrospectively identified SSI
Prospectively and Retrospectively identified HeartMate II patients where the full length of the velour coated portion of the driveline is tunneled under the skin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

December 2018

Estimated Primary Completion Date

December 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has signed the INTERMACS informed consent form
Subject has signed the SSI registry informed consent form
Subject age ≥ 18 years
Subject implanted with a HeartMate II LVAD
Subject in whom the full length of the velour portion of the percutaneous lead is fully kept under the skin resulting in a silicone skin interface at the skin exit site
In the prospective study cohort, Subject is planned to be supported with the HeartMate II LVAD for at least 12 months
In the retrospective study cohort, at the time of enrollment, Subject has been supported with a HeartMate II for at least 10 months

Exclusion Criteria:

In the retrospective study cohort, Subject is ongoing with long-term right heart mechanical circulatory support (RVAD)
In the retrospective study cohort, Subject had a post-implant sternal re-entry (for bleeding, etc.) or delayed sternal closure
In the retrospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
In the prospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01577433

Other Study ID Numbers ^ICMJE

TC11282011

Has Data Monitoring Committee

Responsible Party

Thoratec Corporation

Study Sponsor ^ICMJE

Thoratec Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Faouzi Kallel, PhD

Thoratec Corporation

Information Provided By

Thoratec Corporation

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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