HOPE with the XVIVO Heart Assist to preserve donor hearts for adult transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Filip Rega, MD, PhD
• Email: filip.rega@uzleuven.be
• Phone: +32 16 34 08 43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.