OCS Heart Perfusion Post-Approval Registry

Running, not enrolling

Conditions studied: Transplant

In brief

The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Key facts

Study ID

NCT05047068

Run by

TransMedics

People needed

350

Starts

2021-09-13

Expected to finish

2029-12-01

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
• Recipient Exclusion Criteria:
• Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
• On renal dialysis at time of transplant.
• Donor Exclusion Criteria (for DCD Donor Hearts only):
• Warm ischemic time > 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).

Where it is running

• Cedars Sinai — Los Angeles, 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
• Northwestern Medicine — 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
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York, United States
• Montefiore — The Bronx, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Scott and White — Dallas, Texas, United States
• Medical City Dallas — Dallas, Texas, United States
• Methodist Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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