Driveline Heart-assisted Device Related Infection Clinical Trial
— SSIOfficial title:
Driveline Silicone Skin Interface (SSI) Registry
| NCT number | NCT01577433 |
| Other study ID # | TC11282011 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | December 2018 |
| Verified date | March 2019 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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)
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | December 2018 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Baylor Medical Center | Dallas | Texas |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | St.Vincent's Hospital and Health Services | Indianapolis | Indiana |
| United States | University of Iowa Hospital | Iowa City | Iowa |
| United States | Abbott Northwestern | Minneapolis | Minnesota |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Washington University - Barnes Jewish Hospital | Saint Louis | Missouri |
| United States | Sacred Heart Medical Center | Spokane | Washington |
| United States | Tampa General Hospital | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices | Thoratec Corporation |
United States,
Akhter SA, Ewald GA, Walsh MN, et al. Preliminary driveline infection results from the multicenter silicone-skin-interface (SSI) registry. Abstracts from the ASAIO 59th Annual Conference, p. 61. http://journals.lww.com/asaiojournal/Documents/ASAIO%20Abstracts%202013.pdf
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Freedom from DL infection events at 12 months after LVAD implantation | 12 Months | ||
| Secondary | Percentage of subjects with infection events | Month 1, 3, 6, and every six months up to 60 months post-enrollment | ||
| Secondary | DL infection events per patient year | Month 1, 3, 6, and every 6 months up to 60 months post-enrollment | ||
| Secondary | DL tunneling methods or other factors that might reduce risks of DL related infection events | Month 1, 3, 6, and every 6 months up to 60 months post-enrollment |