US National OCS Heart Perfusion (OHP) Registry

Summary

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Detailed Description

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US. The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.

Eligibility Criteria

Interventions