XVIVO Heart Transplant Study in Clinical Practice (HOPE for All)

August 7, 2026 updated by: XVIVO Perfusion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preservation of DBD and DCD hearts for transplant.
Device: XVIVO Heart Assist Transport System
Revised XHAT
Other Names:
  • Hypothermic oxygenated perfusion - HOPE
  • Direct procurment
  • Non-Ischemic Heart Preservation NIHP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Survival
Time Frame: 30 days post-transplant
30 days post-transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac related mortality at 30 days post-transplant
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of Mechanical circulatory support within 30 days post-transplant
Time Frame: 30-days post-transplant
30-days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant
Time Frame: 24 hours post-transplant
24 hours post-transplant
Incidence of Primary Graft Dysfunction (PGD) RV at 24 hours post-transplant
Time Frame: 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
Time Frame: 24 hours and 30 days post-transplant
24 hours and 30 days post-transplant
Duration of initial ICU stay after the index procedure
Time Frame: 30-days post-transplant
30-days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) within 30 days post-transplant
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of hearts perfused on the investigational device which is not used for transplantation
Time Frame: From enrollment to the end of recruitment
From enrollment to the end of recruitment
Cardiac related mortality at 6 and 12 months post-transplant
Time Frame: 6 and 12 months post-transplant
6 and 12 months post-transplant
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
6 and 12 months post-transplant
Number of days until hospital discharge from index procedure 6 and 12 months post-transplant
Time Frame: 6 and 12 months post-transplant
6 and 12 months post-transplant
Incidence of biopsy proven rejections > 1 ACR leading to changed immunosuppressive regime within 12 months post-transplant
Time Frame: Within 12 months post-transplant
Within 12 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XVIVO Perfusion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2024

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

April 15, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE for All CIV-25-11-055414
  • S71444 (Other Identifier: UZ Leuven Herestraat 49, B-3000 Leuven, Belgium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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