What is the Purpose of this Study?
The purpose of this study is to evaluate whether an organ care system (OCS) solution with an added OCS functional enhancer (OFE) and new gas mixture can preserve donor hearts more safely and effectively than the traditional static cold storage (on ice). The study may improve outcomes by reducing heart swelling and improve donor heart function, potentially allowing more donor hearts to be safely used for transplantation. Participants will be patients who are scheduled to receive a heart transplant and may be eligible to receive a donor heart preserved using either the new OCS Heart System solution or the traditional method. If the donor heart is suitable for both preservation methods, the participant may be randomly assigned to 1 of the 2 groups. The U.S. Food and Drug Administration (FDA) approved the OCS Heart System for preserving donor hearts from both brain-dead donors and donors after circulatory death. In this study, the device is being used with a new OCS Solution and OCS Functional Enhancer (OFE), which is experimental.
Eligibility
- Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):
- * Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- * All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Enhancing Heart Allograft Function with the OCS Heart System Trial