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New registry to see if a heart-preserving device can save more lives in transplants

NCT ID NCT05915299

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 registry will follow up to 100,000 heart transplant recipients to compare outcomes when donor hearts are preserved using the OCS Heart system versus traditional cold storage. The goal is to see if the OCS Heart system, which keeps donor hearts warm and beating during transport, leads to better patient and graft survival. No new treatments are being tested; instead, researchers will analyze existing data from a national transplant database.

What this could mean

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

What this could lead to
If successful, this registry could confirm that the OCS Heart system helps more donor hearts be used safely, potentially increasing transplant access.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or other factors.

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.

Participants

About 100,000 people

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

Started

Aug 2023

Expected to finish

Aug 2033

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.

Who is studied

All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * N/A Exclusion Criteria: * N/A

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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

    37 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

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Aurora St Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Banner University Medical Center Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baylor Scott and White

    RECRUITING

    Dallas, Texas, 75226, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Boulder

    RECRUITING

    Boulder, Colorado, 80309, United States

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Froedtert & the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Henry Ford

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Lucile Packard Children's Hospital Stanford

    RECRUITING

    Palo Alto, California, 94304, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Montefiore

    RECRUITING

    The Bronx, New York, 10467, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55414, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 48109, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98105, United States

  • Virginia Commonwealth University Health

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

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