US National OCS Heart Perfusion Registry for Heart Transplant Patients
This study is an observational registry collecting information on heart transplant patients who receive a donor heart preserved using the TransMedics® Organ Care System (OCS) Heart System. This system is an FDA-approved device designed to keep donor hearts healthy outside the body before transplant. The study aims to understand how well patients and their new hearts do after transplant when the OCS Heart System is used in real-world settings. All heart transplant recipients who receive an OCS-perfused donor heart can join this registry. Researchers will track patient and heart survival for up to five years after the transplant to see how effective the OCS Heart System is.
- Study design
- This is an observational study that plans to enroll 100,000 participants. It is a multi-center registry with independent academic oversight.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' clinical outcomes will be followed for up to five years post-transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
US National OCS Heart Perfusion (OHP) Registry
At a glance
Conditions
NCT05915299
Where you'd take part
This study runs at 37 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atrium Health
Charlotte, North Carolinastudy coordinator listed
Recruiting
Aurora St Luke's Medical Center
Milwaukee, Wisconsinstudy coordinator listed
Recruiting
Baylor Scott and White
Dallas, Texasstudy coordinator listed
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New Yorkstudy coordinator listed
Recruiting
Duke University
Durham, North Carolinastudy coordinator listed
Recruiting
Emory University Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsinstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Recipients' patient and graft survivalUp 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.