XVIVO Heart Transplant Study in Clinical Practice
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXVIVO Perfusion
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not able to understand the information provided during the informed consent procedure
Combined organ transplantation candidates
Functional warm ischemia time (FWIT) > 30 minutes (DCD).
Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (DCD)
Trial design
Design model
Single group
Treatments tested in this trial
XVIVO Heart Assist Transport System
DeviceRevised XHAT
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Preservation of DBD and DCD hearts for transplant.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient Survival
Time frame
30 days post-transplantSecondary outcomes
1
Cardiac related mortality at 30 days post-transplant
Time frame
30 days post-transplant2
Incidence of Mechanical circulatory support within 30 days post-transplant
Time frame
30-days post-transplant3
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant
Time frame
24 hours post-transplant4
Incidence of Primary Graft Dysfunction (PGD) RV at 24 hours post-transplant
Time frame
24 hours post-transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov