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New device aims to keep donor hearts healthier for transplant

NCT ID NCT07556588

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This early trial tests a device that keeps donor hearts cool and oxygenated during transport, instead of the usual ice cooler. The goal is to see if this method is safe and works for heart transplants from both brain-dead and circulatory-death donors. Twenty adult patients awaiting a heart transplant will take part. If it works, it could lead to better heart preservation and more successful transplants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XVIVO Heart Assist Transport System (device for hypothermic oxygenated perfusion of donor hearts)
What this could lead to
If successful, this device could help more donor hearts be safely transported and transplanted, potentially increasing the number of heart transplants available.
What could go wrong
This is a very early, small trial with only 20 patients. The device may not improve outcomes or could have unforeseen complications. Results may not apply to all transplant centers.
Why investors are watching

Xvivo Perfusion is testing its revised Heart Assist Transport System, which keeps donor hearts alive with oxygenated cold fluid during transport, in a 20-patient real-world trial covering both DBD and DCD donor hearts. For a small company whose entire value rests on this device, a positive safety and survival result would validate the product's broader use beyond its current niche. A negative or unclear outcome would directly challenge the company's core commercial story.

If it works: A successful readout could support regulatory and commercial expansion of the Heart Assist system to a wider range of transplant patients, strengthening Xvivo's position in the donor organ preservation market. It might also encourage larger follow-up studies that could lead to broader adoption.

If it fails: The trial is small and single-center, so even a positive result offers limited proof. If the device fails to show acceptable survival or graft function, or if the study stalls, Xvivo would face a setback in its main product line, and investors would likely reassess the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Apr 2028

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 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

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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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UZ Leuven

    RECRUITING

    Leuven, B-3000, Belgium

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