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New device aims to boost heart transplant success

NCT ID NCT07145515

Disease control Sponsor: TransMedics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special machine and solution that keeps donor hearts in better condition during transport, compared to the usual ice-cooler method. The goal is to see if it helps the heart work well right after transplant and improves survival at 30 days. About 655 people receiving a heart transplant will take part.

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 655 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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.

Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications): Donor Inclusion Criteria * Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room. * All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor. * DBD donor hearts with an expected cross clamp of ≥ 4 hours * DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time: * Donor age ≥ 40 years old * Unknown downtime * Insignificant CAD * LVEF ≤ 50% Donor Exclusion • Moderate to severe aortic incompetence Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication): Donor Inclusion Criteria * Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room. * Eligible for randomization to OCS or SCS treatment arms. * DBD donor hearts with an expected cross clamp time of \< 4 hours. Donor Exclusion * Moderate to severe aortic incompetence * DBD donor with any of the following organ quality concerns: * Donor age ≥ 40 years old * Unknown downtime * Insignificant CAD * LVEF ≤ 50% Recipient Eligibility Criteria (for Part A and B Cohorts) Inclusion * Signed informed consent document and authorization to use and disclose protected health information * Heart transplant candidate * Age ≥ 18 years old Exclusion • Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial

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As listed by the trial registrant

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

Heart transplant

How to take part

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

  1. The places running it

    8 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

  • Baylor Scott and White

    RECRUITING

    Dallas, Texas, 75226, United States

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

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