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New machine keeps donor hearts alive for transplant

NCT ID NCT06485596

Disease control Sponsor: XVIVO Perfusion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests a new method to preserve hearts from donors after circulatory death. The hearts are kept cool and oxygenated using a special machine during transport. The goal is to see if this helps more people get heart transplants and survive. The study involves 20 adults already listed for a heart transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, 3015, Netherlands

  • UMC Groningen

    Groningen, 9713, Netherlands

  • UMC Utrecht

    Utrecht, 3584, Netherlands

  • UZ Leuven

    Leuven, Belgium

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