XVIVO PRESERVE (Heart Transplantation) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Heart Transplantation

Who Can Participate in the Study?

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.

Age Group

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

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
Protocol Number
IRB: PRO00113642
NCT: NCT05881278
Phase N/A
Enrollment Status
Open for Enrollment