Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07556588

XVIVO Heart Transplant Study in Clinical Practice

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Recipient:

  • Age ≥18 years
  • Signed informed consent form
  • Accepted or listed for heart transplantation

Inclusion criteria

Heart Donor:

  • 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

Exclusion criteria

Recipient:

  • Not able to understand the information provided during the informed consent procedure
  • Combined organ transplantation candidates

Exclusion criteria

Heart Donor:

  • 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

Treatment and study plan

XVIVO Heart Assist Transport System

Device

Revised XHAT

Other names: Hypothermic oxygenated perfusion - HOPE, Direct procurment, Non-Ischemic Heart Preservation NIHP

Primary outcomes

  1. Patient Survival

    Time frame: 30 days post-transplant

Secondary outcomes

  1. Cardiac related mortality at 30 days post-transplant

    Time frame: 30 days post-transplant

  2. Incidence of Mechanical circulatory support within 30 days post-transplant

    Time frame: 30-days post-transplant

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

    Time frame: 24 hours post-transplant

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

    Time frame: 24 hours post-transplant

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

    Time frame: 24 hours and 30 days post-transplant

  6. Duration of initial ICU stay after the index procedure

    Time frame: 30-days post-transplant

  7. Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) within 30 days post-transplant

    Time frame: 30 days post-transplant

  8. Incidence of hearts perfused on the investigational device which is not used for transplantation

    Time frame: From enrollment to the end of recruitment

  9. Cardiac related mortality at 6 and 12 months post-transplant

    Time frame: 6 and 12 months post-transplant

  10. Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 6 and 12 months post-transplant

    Time frame: 6 and 12 months post-transplant

  11. Number of days until hospital discharge from index procedure 6 and 12 months post-transplant

    Time frame: 6 and 12 months post-transplant

  12. Incidence of biopsy proven rejections > 1 ACR leading to changed immunosuppressive regime within 12 months post-transplant

    Time frame: Within 12 months post-transplant

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Rega, MD, PhD

CONTACT

[email protected]

+32 16 34 08 43

Janne Brouckaert, MD

CONTACT

[email protected]

+3216346278

Sponsors and collaborators

Lead sponsor

XVIVO Perfusion

Industry

Registry information

Official study title

Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All

Acronym: HOPE for All

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.