Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07556588

XVIVO Heart Transplant Study in Clinical Practice

Led by XVIVO Perfusion · Updated on 2026-04-29

20

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

HOPE for All is a clinical investigation to support the use of hypothermic oxygenated perfusion (HOPE) using a revised XVIVO Heart Assist Transport System in a real- world setting. The trial will investigate the application of HOPE in a broad population of Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donor hearts transplanted to any listed adult patient. The hypothesis is that the use of HOPE is safe and feasible for any adult patient awaiting a heart transplantation. Primary objective is to evaluate patient survival in the real world setting after heart transplantation, where HOPE using the revised XVIVO Heart Assist Transport System is used for donor heart preservation. Secondary objective(s) are to evaluate patient outcomes and graft function post-transplant. HOPE for All is a prospective, single-armed single-centre proof-of-consept trial.

CONDITIONS

Official Title

XVIVO Heart Transplant Study in Clinical Practice

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years
  • Signed informed consent form
  • Accepted or listed for heart transplantation
  • Heart donor accepted by transplant team based on standard care criteria
  • Donor heart from DBD or DCD Maastricht category III or euthanasia donors
Not Eligible

You will not qualify if you...

  • Unable to understand information during informed consent procedure
  • Candidates for combined organ transplantation
  • Functional warm ischemia time over 30 minutes for DCD donors
  • Donor cardiac arrest not occurring within 120 minutes from withdrawal of life support (DCD)
  • Deviations from donor end of life treatment protocol per local procedures
  • Donor heart assessed as not transplantable by responsible clinician at any time during donation or procurement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, B-3000

Actively Recruiting

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Research Team

F

Filip Rega, MD, PhD

CONTACT

J

Janne Brouckaert, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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XVIVO Heart Transplant Study in Clinical Practice | DecenTrialz