XVIVO Heart Transplant Study in Clinical Practice

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.

HOPE for All will include a total of 20 subjects transplanted with donor hearts using the revised XVIVO Heart Assist Transport System and will evaluate transplant outcomes such as patient survival, post-transplant complications and graft function for a period of 12 months post-transplant.

The investigation will be conducted at 1 heart transplant center in Belgium who has thorough experience using the XVIVO Heart Assist Transport System for both DBD and DCD transplants.

The study will not include a control group as this is a proof-of-concept study

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