Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Driveline Silicone Skin Interface Registry (SSI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01577433
First received: April 11, 2012
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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)


Condition
Driveline Heart-assisted Device Related Infection

Study Type: Observational
Official Title: Driveline Silicone Skin Interface (SSI) Registry

Further study details as provided by Thoratec Corporation:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577433

Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Indiana
St.Vincent's Hospital and Health Services
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Abbott Northwestern
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Washington University - Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Baylor Medical Center
Dallas, Texas, United States, 75226
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: Faouzi Kallel, PhD Thoratec Corporation
  More Information

No publications provided

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01577433     History of Changes
Other Study ID Numbers: TC11282011
Study First Received: April 11, 2012
Last Updated: October 27, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Thoratec Corporation:
HeartMate II
heart-assist device
left ventricular assist device
driveline infection
LVAD
HMII LVAS driveline
silicone portion

Additional relevant MeSH terms:
Infection
Prosthesis-Related Infections
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on November 20, 2014