Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, B-3000
Actively Recruiting
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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