What is the Purpose of this Study?
The purpose of this study is to evaluate the safety of using hearts from donors after circulatory death (DCD) compared to hearts from donors after brain death (DBD) in individuals who have been listed to receive a heart transplant. The study will evaluate whether patients who receive a DCD heart transplant have similar outcomes as patients who receive DBD hearts. In the U.S., heart donation occurs after a person has been declared brain dead (donor after brain death- DBD). After life support is withdrawn, organs are retrieved for transplantation. In this study, some participants will receive hearts from donors after circulatory death (DCD). DCD donors are those whose hearts have stopped beating and no longer pump blood. Participants will receive whichever heart (DCD or DBD) is available first.
Eligibility
- Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
- Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
- Male or female, aged 18 years of age or older listed for primary heart transplant
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Evaluating the Safety of Normothermic Regional Perfusion and Direct Procurement and Perfusion for Procurement and Transplantation of Donor Hearts from Donation after Circulatory Death Donors: A Single Center Pilot