Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Thoratec Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from DL infection events at 12 months after LVAD implantation | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with infection events | Month 1, 3, 6, and every six months up to 60 months post-enrollment | |
| DL infection events per patient year | Month 1, 3, 6, and every 6 months up to 60 months post-enrollment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Farrar, PhD | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States | ||
| Tampa General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Tampa |
| Florida |
| 33606 |
| United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| St.Vincent's Hospital and Health Services | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospital | Iowa City | Iowa | 52242 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Abbott Northwestern | Minneapolis | Minnesota | 55407 | United States |
| Washington University - Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Baylor Medical Center | Dallas | Texas | 75226 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |