Enhancing Heart Allograft Function With the OCS Heart System Trial
Recruiting now · Not applicable
Conditions studied: Heart Transplant
In brief
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
Key facts
- Study ID
- NCT07145515
- Run by
- TransMedics
- People needed
- 655
- Starts
- 2026-01-01
- Expected to finish
- 2027-07-30
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California San Francisco — San Francisco, California, United States (enrolling)
- Tampa General Hospital — Tampa, Florida, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Mount Sinai — New York, New York, United States (enrolling)
- Baylor Scott and White — Dallas, Texas, United States (enrolling)
- Westchester Medical Center — Valhalla, New York, United States (enrolling)
- Duke University — Durham, North Carolina, United States (enrolling)
- Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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