Purpose of this Study
We are doing this study to find out if the XVIVO Heart Preservation System (the study device) is a safe and effective technology that can preserve and maintain extended criteria donor hearts for transplantation.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are on the waiting list to receive a heart transplant at Duke
- Have not received and are not expecting any other type of organ 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
If you agree to join this study, you will get 1 of 2 hearts (whichever one becomes available first):
- A heart from a conventional donor; OR
- A heart from an extended criteria donor that has been preserved and maintained using the study device
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors
Principal Investigator
Jacob
Schroder
Protocol Number
PRO00113642
NCT ID
NCT05881278
Phase
N/A
Enrollment Status
Open to Enrollment