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.
Who Can Participate?
Eligibility
Adults who are candidates for a heart transplant.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Enhancing Heart Allograft Function with the OCS Heart System (ENHANCE) Trial
Principal Investigator
Jacob
Schroder
Protocol Number
PRO00118965
NCT ID
NCT07145515
Phase
N/A
Enrollment Status
Pending Open to Enrollment