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OCS Heart ENHANCE - Clinical Trial

What is the Purpose of this Study?

People in this study may get a donor heart that is kept safe using a special system called the OCS Heart System, or they may get a heart kept cold in the usual way. Which one they get depends on the heart they are matched with. After the transplant, the study will collect information from their medical records for six months.

What is the Condition Being Studied?

Heart Transplantation

Who Can Participate in the Study?

Adults who are candidates for a heart transplant.

Age Group
Adults

What is Involved?

The OCS Heart System is a machine that helps keep donor hearts safe and healthy before a transplant. It is approved by the FDA and is often used at Duke. For this study, the liquid and gas used with the machine have been changed. These changes are new and not yet approved by the FDA. The study wants to see if these new parts can keep hearts safe while they are being moved back to Duke for transplant.

Study Details

Full Title
Enhancing Heart Allograft Function with the OCS Heart System (ENHANCE) Trial
Principal Investigator
Protocol Number
IRB: PRO00118965
NCT: NCT07145515
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon