HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. (HOPE@Heart)

July 31, 2026 updated by: XVIVO Perfusion

Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System

The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death.

The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.

The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, multi-national, multicentre, proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxygenated perfusion of the donor heart in DCD using the XVIVO Heart Assist Transport system.

The investigation will be conducted at 4 heart transplant centres, one in Belgium and three in The Netherlands.The study will include 40 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications, patient survival and graft function for a period of 6 months post-transplant.

The study will not include a control group as this is a proof-of-concept study, investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data.

The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.

The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • Netherlands
      • Groningen, Netherlands, 9713
        • UMC Groningen
      • Rotterdam, Netherlands, 3015
        • Erasmus MC
      • Utrecht, Netherlands, 3584
        • UMC Utrecht

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 Recipient Criteria:

  1. Age ≥18 years
  2. Signed informed consent form
  3. Accepted and/or listed for heart transplantation

Exclusion Recipient Criteria:

  1. Not able to understand the information provided during the informed consent procedure
  2. Previous solid organ transplantation
  3. Grown-up congenital heart disease
  4. Dialysis
  5. Incompatible blood group
  6. Combined organ transplantation candidates
  7. Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
  8. Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)

Inclusion - Heart donor

  1. Accepted as a heart donor by the transplant team based on current standard of care criteria
  2. DCD Maastricht category III and euthanasia donors
  3. Age ≤ 60 years old

Exclusion - Heart Donor

  1. Functional warm ischemia time (FWIT) > 30 minutes.
  2. Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (WLST)
  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: DCD Direct procurement
Direct procurement of DCD donor hearts
Device: XVIVO Heart Assist Transport System
Direct procurement of donor hearts from DCD donation
Other Names:
  • Direct procurement

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
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of Mechanical circulatory support
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014)
Time Frame: 30 days post-transplant
30 days post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of perfused hearts which are not used for transplantation
Time Frame: 30 days post-transplant
30 days post-transplant
Total duration of ICU stay (days)
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
Time Frame: 30 days post-transplant
30 days post-transplant
Cardiac related mortality at 6 months post-transplant
Time Frame: 6 months post-transplant
6 months post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF)
Time Frame: 6 months post-transplant
6 months post-transplant
Number of days until hospital discharge from index procedure
Time Frame: 30 days post-transplant
30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
Time Frame: 6 months post-transplant
6 months post-transplant

Collaborators and Investigators

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

Sponsor

XVIVO Perfusion

Investigators

  • Principal Investigator: Filip Rega, MD, PhD, UZ Leuven

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)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE at Heart

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

product manufactured in and exported from the U.S.

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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