NCT07556588Recruiting
XVIVO Heart Transplant Study in Clinical Practice
Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 3 Aug 2024
- Primary completion date
- 15 May 2027
- Lead sponsor
- XVIVO Perfusion
- Diseases
- Heart failure
- NCT number
- NCT07556588
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 3 Aug 2024 to the primary completion date, 15 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Combined organ transplantation candidates
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.