OCS Heart Perfusion Registry

Multi-center, observational post-approval registry to compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period. 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 donor hearts.

Inclusion Criteria

Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.

Exclusion Criteria

Adult primary heart transplant recipients of DBD donor hearts perfused on OCS Heart System except for the following recipient exclusion criteria:

• Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or

• On renal dialysis at time of transplant

Study Requirements