Driveline Silicone Skin Interface Registry (SSI)
This study is currently recruiting participants.
Verified May 2013 by Thoratec Corporation
Sponsor:
Thoratec Corporation
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577433
Locations
| United States, Connecticut | |
| Yale New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Lynn Wilson lynn.wilson@ynhh.org | |
| Principal Investigator: Abeel Mangi, MD | |
| United States, Florida | |
| Tampa General Hospital | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Aimee Jopling ajopling@tgh.org | |
| Principal Investigator: Christiano Caldeira, MD | |
| United States, Georgia | |
| Piedmont Heart Institute | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Jeanette Turner jeanette.turner@piedmont.org | |
| Principal Investigator: David Dean, MD | |
| United States, Illinois | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Becki Pisarski bpisarski@surgery.bsd.uchicago.edu | |
| Principal Investigator: Shahab Akthar, MD | |
| Advocate Christ Medical Center | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Mary Jane Borg mborg@ctvsurgeons.com | |
| Principal Investigator: Antone Tatooles, MD | |
| Sub-Investigator: Pat Pappas, MD | |
| United States, Indiana | |
| St.Vincent's Hospital and Health Services | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Regina Margiotti rmargiotti@thecaregroup.com | |
| Principal Investigator: Mary Walsh, MD | |
| United States, Iowa | |
| University of Iowa Hospital | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Page Scovel page-scovel@uiowa.edu | |
| Principal Investigator: Jennifer Goerbig-Campbell, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Andrei Rus arus1@hfhs.org | |
| Principal Investigator: Robert Brewer, MD | |
| United States, Minnesota | |
| Abbott Northwestern | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Susan Gjersvik susan.falk@allina.com | |
| Principal Investigator: Benjamin Sun, MD | |
| United States, Missouri | |
| Washington University - Barnes Jewish Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Jean Flanagan jflanaga@dom.wustl.edu | |
| Principal Investigator: Gregory Ewald, MD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Deanna Ravenscraft deanna_ravenscraft@med.unc.edu | |
| Principal Investigator: Brett Sheridan, MD | |
| United States, Texas | |
| Baylor Medical Center | Recruiting |
| Dallas, Texas, United States, 75226 | |
| Contact: JaKarsha Culton jakarsc@baylorhealth.edu | |
| Principal Investigator: Shelley Hall, MD | |
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84107 | |
| Contact: Marsha Eidson marsha.eidson@imail.org | |
| Principal Investigator: Bruce Reid, MD | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Joyce Hager jhager@mcvh-vcu.edu | |
| Principal Investigator: Daniel Tang, MD | |
| United States, Washington | |
| Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Suzanne Puhlman suzanne.puhlman@providence.org | |
| Principal Investigator: Timothy Icenogle, MD | |
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: | May 14, 2013 |
| 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:
|
Prosthesis-Related Infections Infection Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013