Purpose of this Study
We are doing this study to find out if Non-Ischemic Heart Preservation using an experimental technology called the XVIVO Heart Preservation System (the study technology) is a safe and effective way to preserve extended criteria donor hearts that can be transplanted into patients who need a donor heart. The study technology is designed to preserve donor hearts using a device with a temperature-controlled perfusion solution that flows through the heart during transport. We want to know if this can allow donor hearts to travel a greater distance to patients who are awaiting a transplant.
Who Can Participate?
Eligibility
Adults ages 18+ who are listed for and awaiting heart transplantation.
For more information, contact the study team at hillary.hood@gmail.com.
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 choose to join this study, you will either:
- Get an extended criteria donor heart preserved on the study technology; OR
- Get a donor heart from conventional methods
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors Continued Access Protocol
Principal Investigator
Jacob
Schroder
Protocol Number
PRO00118060
NCT ID
NCT06895070
Phase
N/A
Enrollment Status
Pending Open to Enrollment