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Clinical Trials in Belgium / NCT07556588
Recruiting Not applicable

XVIVO Heart Transplant Study in Clinical Practice

NCT07556588 · tracked via the Priya Life Science Belgium tracker
Sponsor
XVIVO Perfusion
Phase
Not applicable
Started
2024-08-03
Last updated
2026-08-12

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

XVIVO Heart Assist Transport System

XVIVO Heart Assist Transport System: Revised XHAT

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Belgium Recruiting

More XVIVO Perfusion trials in Belgium

HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. Active, not recruiting
Non-ischemic Preservation of the Donor Heart in Heart Transplantation Active, not recruiting

Other trials for the same condition

AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT Active, not recruiting
HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. Active, not recruiting
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices Active, not recruiting
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure Recruiting
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07556588 on ClinicalTrials.gov ↗ ← All trials in Belgium