OCS Heart Perfusion Post-Approval Registry

Launched by TRANSMEDICS · Sep 8, 2021

Keywords

ClinConnect Summary

The OCS Heart Perfusion Post-Approval Registry is a study looking at how well the OCS Heart System works for preserving hearts from donors for heart transplant patients. It aims to gather more information about this system in real-life situations, especially for hearts from donors who have died from brain death (DBD) or donors whose hearts have stopped beating (DCD). This registry is currently active but not recruiting new participants.

To be eligible for this study, you need to be an adult who is receiving a heart transplant using a heart from a DBD or DCD donor that has been preserved with the OCS Heart System. However, you cannot have had another solid organ transplant, like a kidney or liver transplant, or be on kidney dialysis at the time of your heart transplant. If you are interested in this study, it’s important to know that it focuses on collecting information after the heart transplant to ensure the OCS Heart System is effective and safe in real-world settings.

Gender

ALL

Eligibility criteria

• 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).