OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.
The objective of this sponsor-initiated OHP-II Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and document the performance of the OCS device in the real-world setting.
All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled.
All interested U.S. Heart transplant centers that use the OCS Heart System for donor heart perfusion will constitute the OHP-II Registry participating centers.
