Keeping donor hearts healthy with oxygenated cooled perfusion before heart transplant
Tests a device preserving donor hearts for adults with heart failure awaiting transplant.
Plain-language title generated from the registry record
Registry title: XVIVO Heart Transplant Study in Clinical Practice
Key facts
- Where
- Leuven, BelgiumSee the site
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- XVIVO Perfusion
- Trial code
- NCT07556588
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All
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.
Inclusion: Age ≥18 years; Signed informed consent form; Accepted or listed for heart transplantation; Accepted as a heart donor by the transplant team based on current standard of care criteria; DBD or DCD Maastricht category III or euthanasia donors.
Exclusion: Combined organ transplantation candidates; Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (DCD); Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure; Not able to understand the information provided during the informed consent procedure; Functional warm ischemia time (FWIT) > 30 minutes (DCD); Deviations from Donor end of life treatment protocol as defined by local standard operating procedures.