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Warmer storage for donor hearts put to the test

NCT ID NCT07818941

Symptom relief Sponsor: John Trahanas 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are studying whether donor hearts can be safely stored and transported at 10°C using a portable cooler called the X°Port Heart Preservation System. The trial enrolls up to 25 adults who are listed for heart transplantation. Participants receive a standard heart transplant, but the donor heart is kept at 10°C instead of the usual colder temperature. The team tracks recovery in the ICU and hospital, looking for signs of severe primary graft dysfunction and other complications.

What this could mean

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

Active substance
the X°Port Heart Preservation System, a portable cooler that keeps donor hearts at 10°C during storage and transport
What this could lead to
If it works, this could give transplant teams a new way to preserve donor hearts, possibly improving outcomes and expanding the pool of usable organs.
What could go wrong
This is an early feasibility study with only 25 participants, so it cannot prove the approach works better than standard care. Donor hearts may still fail, and patients could need machines like ECMO to support circulation after surgery.

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 25 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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 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.

Recipient Inclusion Criteria: * Age \>=18 years old * Listed for heart transplantation * Consented for the research study (signed Informed Consent Form) Recipient Exclusion Criteria: * Multi-organ transplant (i.e., heart-liver, heart-kidney, heart-lung) * Previous solid organ or bone marrow transplant * Complex congenital etiology of heart failure Donor Inclusion Criteria: * Donation after brain death or donation after circulatory death heart donors * Donor hearts that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible. Donor Exclusion Criteria: * Donor hearts that have been allocated to VUMC as a backup offer * Donor hearts that have been allocated to VUMC as a post-procurement offer * Donor hearts that have already been placed on ice

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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 Heart transplant Transplant, failure, heart

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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