HOPE with the XVIVO Heart Assist to preserve donor hearts for adult transplant patients
Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All
This will try using hypothermic oxygenated perfusion (HOPE) with the revised XVIVO Heart Assist Transport System to preserve donor hearts for adults awaiting a heart transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | XVIVO Perfusion Industry-sponsored |
| Locations | 1 site (Leuven) |
| Trial ID | NCT07556588 on ClinicalTrials.gov |
What this trial studies
HOPE for All is a prospective, single-arm, single-center proof-of-concept study that will use the revised XVIVO Heart Assist Transport System to perfuse donor hearts from both DBD and DCD donors. The trial plans to enroll 20 adult transplant recipients whose donor hearts are preserved with HOPE and follow them for 12 months after transplantation. Primary outcome is patient survival in a real-world clinical setting, with secondary outcomes including post-transplant complications and graft function. There is no control group in this initial feasibility evaluation at a single experienced center in Belgium.
Who should consider this trial
Good fit: Adults (≥18 years) who are listed or accepted for heart transplantation at the participating center and able to give informed consent are appropriate candidates.
Not a fit: Patients who cannot provide informed consent, those listed for combined organ transplants, or those not receiving a HOPE-preserved donor heart are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, HOPE could improve donor heart preservation and lead to better patient survival and graft function after transplantation.
How similar studies have performed: Previous single-center use of the XVIVO Heart Assist and hypothermic oxygenated perfusion has shown feasibility and encouraging outcomes for DBD and DCD hearts, though large randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Filip Rega, MD, PhD
- Email: filip.rega@uzleuven.be
- Phone: +32 16 34 08 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.