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
For more information about this study, please contact the study team at susan.hajmohammad@duke.edu.
- 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
For more information about this study, please contact the study team at susan.hajmohammad@duke.edu.
What is Involved?
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
- A heart from a conventional donor; OR
- A heart from an extended criteria donor that has been preserved and maintained using the study device
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 ACCRUAL