US National OCS Heart Perfusion (OHP) Registry
1 other identifier
observational
100,000
1 country
37
Brief Summary
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2033
October 30, 2025
September 1, 2025
6 years
June 13, 2023
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
OCS Heart Transplant Recipients
All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
Interventions
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.
Eligibility Criteria
All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
You may qualify if:
- N/A
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (37)
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
University of California San Diego
La Jolla, California, 92037, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304, United States
Stanford University
Palo Alto, California, 94304, United States
University of California San Francisco
San Francisco, California, 94143, United States
Boulder
Boulder, Colorado, 80309, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford
Detroit, Michigan, 48202, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, 10032, United States
Montefiore
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina
Chapel Hill, North Carolina, 48109, United States
Atrium Health
Charlotte, North Carolina, 28203, United States
Duke University
Durham, North Carolina, 27710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor Scott and White
Dallas, Texas, 75226, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University Health
Richmond, Virginia, 23298, United States
University of Washington Medical Center
Seattle, Washington, 98105, United States
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 22, 2023
Study Start
August 25, 2023
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2033
Last Updated
October 30, 2025
Record last verified: 2025-09