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New device could keep donor hearts alive longer outside the body

NCT ID NCT06035991

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a device that keeps donor hearts alive outside the body for longer periods before transplant. The goal is to see if hearts preserved this way work well within 15 days after surgery. Twenty adults with severe heart failure who cannot get a standard transplant are participating.

What this could mean

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

Active substance
ex-vivo heart perfusion device
What this could lead to
If successful, this could allow donor hearts to be preserved for longer periods, potentially increasing the number of hearts available for transplant.
What could go wrong
This is a very early, small trial with only 20 participants. The device may not work as hoped, and there are always risks with any transplant surgery, including organ rejection or failure.

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

Oct 2023

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 100 years

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: * Patients over 18 years of age * Patients suffering from irreversible terminal heart failure with a medical indication for heart transplantation but who cannot be transplanted (per the graft allocation policy in France) or assisted (technical impossibility, contraindication, patient's refusal) and for whom a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière has been made * Having given their informed consent in writing Exclusion Criteria: * Technical obstacles which would generate an excessive surgical risk for the patient according to the medical opinion such as comorbidities or associated pathology not compatible with a transplant * Known ongoing sepsis, defined as positive blood culture immediately prior to transplant (including with ventricular assist device) * Candidate patient for Combined Organ Transplantation * Patient protected by law (guardianship, curatorship, deprived of liberty) * No affiliated with or entitled to a French social security scheme (AME included) * Pregnant or breast-feeding female * Current participation in another interventional study (category 1 of French Jardé law) or being in the exclusion period at the end of a previous study * Patient unable to understand the information provided during the informed consent 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 transplantation

Contacts and locations

Locations

  • Pitié-Salpêtrière Hospital

    Paris, 75013, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.