US National OCS Heart Perfusion (OHP) Registry
- Conditions
- Heart Transplant
- Interventions
- Device: OCS Heart
- Registration Number
- NCT05915299
- Lead Sponsor
- TransMedics
- Brief Summary
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100000
- N/A
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OCS Heart Transplant Recipients OCS Heart All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled.
- Primary Outcome Measures
Name Time Method Recipients' patient and graft survival Up to 5 years post-transplant 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
University of California San Diago
🇺🇸La Jolla, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Montefiore
🇺🇸Bronx, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
Nyph/Cumc
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baylor Scott and White
🇺🇸Dallas, Texas, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Aurora St Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Froedtert & the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States