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New device could keep donor hearts alive longer for transplant

NCT ID NCT06895070

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests a device that keeps donor hearts functioning outside the body without stopping blood flow. It aims to safely use hearts from extended-criteria donors (e.g., older or with other health issues) for transplant. Sixty adult heart transplant recipients will receive a heart preserved this way, and researchers will check survival and success at 30 days and one year.

What this could mean

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

Active substance
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) – a device that keeps donor hearts functioning outside the body
What this could lead to
If successful, this could allow more donor hearts to be used for transplant, helping people with heart failure get a new heart sooner.
What could go wrong
This is an early-stage study with only 60 participants, so results may not apply to everyone. The device is new, and there could be unforeseen risks during preservation or 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

About 60 people

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

Started

Jul 2025

Expected to finish

May 2031

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: To be eligible to participate in this study, a recipient must meet all the following criteria: 1. Age ³18 years. 2. Signed informed consent form (ICF). 3. Listed for heart transplantation. Exclusion Criteria Recipient: 1. Previous solid organ or bone marrow transplantation. 2. Requires a multi-organ transplant. 3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted). 4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP). 5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review). 6. Subject on renal replacement therapy/dialysis. 7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent). 8. Sensitized participants meeting any of the following: * Participant with calculated Panel Reactive Antibody (cPRA) greater than 50% * Participant undergoing any desensitization treatment (also with cPRA less than 50%) * Participant with a positive prospective crossmatch and/or a positive virtual cross match Donor Inclusion Criteria: To be eligible to participate in this study, the donor heart must meet the following criteria: 1. Estimated Cross Clamp Time ≥4 hours OR 2. Estimated Cross Clamp ≥ 2 hours AND Any one or more of the following: * Age ≥50 years * LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance). * Down-time ≥20 minutes * Hypertrophy septal thickness \>12 - ≤16mm * Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD) Donor Exclusion Criteria: Donor hearts that meet any of the following criteria will be excluded from transplantation in this study: 1. Unstable hemodynamics requiring high-dose inotropic support. 2. Significantly abnormal coronary angiogram defined as CAD \> 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination. 3. Moderate to severe cardiac valve pathology. 4. Investigator's clinical decision to exclude from trial. 5. Previous sternotomy.

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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

    14 sites. 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

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Columbia University Medical Center/New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611-5969, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • UC San Diego Health

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095-1405, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 69198-2265, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University - Barnes Jewish Health Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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