US National OCS Heart Perfusion (OHP) Registry
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- TransMedics
- Study ID
- NCT05915299
- Status
- Recruiting
Conditions
- Heart Transplant
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- OCS Heart — DEVICEThe 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.
Study Details
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
Key Dates
- Start date
- Aug 25, 2023
- Status verified
- Sep 2025
- Primary completion
- Aug 31, 2029
- Completion
- Aug 31, 2033
Study Design
- Enrollment
- 100,000 participants (estimated)
Arms
- Arm: OCS Heart Transplant RecipientsAll heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
Primary Outcome Measure
Recipients' patient and graft survival [ Time Frame: Up to 5 years post-transplant ]
Central Contacts
- Raicca Haqqi9788090620
- Kausar Qidwai
Locations (37)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | Raelyn McGarry Francisco Arabia, MD (PRINCIPAL_INVESTIGATOR) |
| University of California San Diego | La Jolla | California | 92037 | Victor Pretorius, MD (PRINCIPAL_INVESTIGATOR) |
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | Tiffany Koyano Michael Ma, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford University | Palo Alto | California | 94304 | Yasuhiro Shudo, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco | San Francisco | California | 94143 | Cherry Ng Liviu Klein, MD (PRINCIPAL_INVESTIGATOR) |
| Boulder | Boulder | Colorado | 80309 | Nargis Kalia, MPH Jordan Hoffmans, MD (PRINCIPAL_INVESTIGATOR) |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | Muhammad Anwer, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Basar Sareyyupoglu, MD (PRINCIPAL_INVESTIGATOR) |
| Tampa General Hospital | Tampa | Florida | 33606 | Lucian Lozonschi, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University Hospital | Atlanta | Georgia | 30322 | Joshua Chan, MD (PRINCIPAL_INVESTIGATOR) |
| University of Chicago | Chicago | Illinois | 60637 | Christopher Salerno, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kentucky | Lexington | Kentucky | 40506 | Matthias Loebe, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Masash Kai, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | David D'Alessandro, MD (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Gaurav Das Gregory Couper, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | China Green Jonathan Haft, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford | Detroit | Michigan | 48202 | Celeste Williams, MD (PRINCIPAL_INVESTIGATOR) |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | Benjamin Sun, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55414 | Andrew Shaffer, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Jolene Erola Mauricio Villavicencio, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University Irving Medical Center/ New York Presbyterian Hospital | New York | New York | 10032 | Bo Lu Koji Takeda, MD (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai | New York | New York | 10029 | Favio Herbas Anelechi Anyanwu, MD (PRINCIPAL_INVESTIGATOR) |
| Montefiore | The Bronx | New York | 10467 | Agnieszka Siemienik Daniel Goldstein, MD (PRINCIPAL_INVESTIGATOR) |
| Westchester Medical Center | Valhalla | New York | 10595 | Corazon DeLaPena David Spielvogel, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina | Chapel Hill | North Carolina | 48109 | Aurelie Merlo, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health | Charlotte | North Carolina | 28203 | Susan Bernardo Eric Skipper, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27710 | Jacob Schroder, MD (PRINCIPAL_INVESTIGATOR) |
| The Christ Hospital | Cincinnati | Ohio | 45219 | William Stewart Robert Hooker, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | David Kaczorowski, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Arman Kilic, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott and White | Dallas | Texas | 75226 | Dan Meyer, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Southwestern | Dallas | Texas | 75390 | Maryjane Farr, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84132 | Craig Selzman, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Commonwealth University Health | Richmond | Virginia | 23298 | Giorgi Mchedkushvili Jinfeng Han Mohammed Quader, MD (PRINCIPAL_INVESTIGATOR) |
| University of Washington Medical Center | Seattle | Washington | 98105 | Jay Pal, MD (PRINCIPAL_INVESTIGATOR) |
| Aurora St Luke's Medical Center | Milwaukee | Wisconsin | 53215 | Jillian Lux Nasir Sulemanjee, MD (PRINCIPAL_INVESTIGATOR) |
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Kelly Potzner Lucian Durham, MD (PRINCIPAL_INVESTIGATOR) |
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