NCT07556588 XVIVO Heart Transplant Study in Clinical Practice
| NCT ID | NCT07556588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | XVIVO Perfusion |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-04-15 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria Recipient: 1. Age ≥18 years 2. Signed informed consent form 3. Accepted or listed for heart transplantation Inclusion Criteria Heart Donor: 1. Accepted as a heart donor by the transplant team based on current standard of care criteria 2. DBD or DCD Maastricht category III or euthanasia donors Exclusion Criteria Recipient: 1. Not able to understand the information provided during the informed consent procedure 2. Combined organ transplantation candidates Exclusion Criteria Heart Donor: 1. Functional warm ischemia time (FWIT) \> 30 minutes (DCD). 2. Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (DCD) 3. Deviations from Donor end of life treatment protocol as defined by local standard operating procedures 4. Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07556588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07556588 currently recruiting?
Yes, NCT07556588 is actively recruiting participants. Contact the research team at filip.rega@uzleuven.be for enrollment information.
Where is the NCT07556588 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07556588 clinical trial?
NCT07556588 is sponsored by XVIVO Perfusion. The trial plans to enroll 20 participants.
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