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XVIVO PRESERVE CAP (Heart Transplant) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Heart Transplantation

Who Can Participate in the Study?

Adults ages 18+ who are listed for and awaiting heart transplantation.

For more information, contact the study team at hillary.hood@gmail.com.

Age Group
Adults

What is Involved?

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.

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
Protocol Number
IRB: PRO00118060
NCT: NCT06895070
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon