Summary

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.

Age: 18 Years and older

Gender: All

Start Date: 09/13/2021

Primary Completion Date (Estimated): 12/01/2025

Study Completion Date (Estimated): 12/01/2029

Accepts Healthy Volunteers: No

Trial Purpose and Description

Multi-center, observational post-approval registry to: 1. 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, and 2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD 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.

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* 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).