XVIVO Heart Transplant Study in Clinical Practice

NCT07556588 | Recruiting

• 2 other identifiers: HOPE for All CIV-25-11-055414S71444
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Patient Survival

  30 days post-transplant

Secondary Outcomes (12)

• Cardiac related mortality at 30 days post-transplant

  30 days post-transplant

• Incidence of Mechanical circulatory support within 30 days post-transplant

  30-days post-transplant

• Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant

  24 hours post-transplant

• Incidence of Primary Graft Dysfunction (PGD) RV at 24 hours post-transplant

  24 hours post-transplant

• Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant

  24 hours and 30 days post-transplant

Study Arms (1)

Preservation of DBD and DCD hearts for transplant.

EXPERIMENTAL

Device: XVIVO Heart Assist Transport System

Interventions

XVIVO Heart Assist Transport System DEVICE

Revised XHAT

Also known as: Hypothermic oxygenated perfusion - HOPE, Direct procurment, Non-Ischemic Heart Preservation NIHP

Preservation of DBD and DCD hearts for transplant.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• DBD or DCD Maastricht category III or euthanasia donors

You may not qualify if:

• 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)
• Deviations from Donor end of life treatment protocol as defined by local standard operating procedures
• Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure

Sponsors & Collaborators

• XVIVO Perfusion: lead

Study Sites (1)

UZ Leuven

Leuven, B-3000, Belgium

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Filip Rega, MD, PhD

CONTACT

+32 16 34 08 43; filip.rega@uzleuven.be

Janne Brouckaert, MD

CONTACT

+3216346278; Janne.brouckaert@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): April 15, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)