XVIVO PRESERVE CAP (Heart Transplant)

XVIVO PRESERVE CAP (Heart Transplant)

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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
If you do receive a heart transplant while participating in this study, the type of donor heart you get from the 2 options in the study will be whichever is available to you first. We will collect information from your medical records from routine follow-up visits for up to 5 years after your transplant. We will also ask you to fill out surveys about how you are feeling.

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