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
Not provided
Not provided
Not provided
Not provided
Not provided
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.
The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Heart Transplant Recipients | All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Heart | Device | The TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation. |
| Measure | Description | Time Frame |
|---|---|---|
| Recipients' patient and graft survival | Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database. | Up to 5 years post-transplant |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raicca Haqqi | Contact | 9788090620 | rhaqqi@transmedics.com | |
| Kausar Qidwai | Contact | kqidwai@transmedics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Recruiting | Phoenix | Arizona | 85006 | United States |
Not provided
Not provided
Not provided
Not provided
|
| University of California San Diego | Recruiting | La Jolla | California | 92037 | United States |
|
| Lucile Packard Children's Hospital Stanford | Recruiting | Palo Alto | California | 94304 | United States |
|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
|
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| Boulder | Recruiting | Boulder | Colorado | 80309 | United States |
|
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
|
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
|
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Henry Ford | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Minneapolis Heart Institute | Recruiting | Minneapolis | Minnesota | 55407 | United States |
|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
|
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Columbia University Irving Medical Center/ New York Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
|
| Montefiore | Recruiting | The Bronx | New York | 10467 | United States |
|
| Westchester Medical Center | Recruiting | Valhalla | New York | 10595 | United States |
|
| University of North Carolina | Recruiting | Chapel Hill | North Carolina | 48109 | United States |
|
| Atrium Health | Recruiting | Charlotte | North Carolina | 28203 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
|
| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| Baylor Scott and White | Recruiting | Dallas | Texas | 75226 | United States |
|
| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| Virginia Commonwealth University Health | Recruiting | Richmond | Virginia | 23298 | United States |
|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98105 | United States |
|
| Aurora St Luke's Medical Center | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
|
| Froedtert & the Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|