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Beating heart machine for transplants under Real-World watch

NCT ID NCT05047068

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This registry follows 350 adult heart transplant patients whose donor hearts were kept alive and beating using the OCS Heart System before transplant. The goal is to see how well patients do one year after surgery. The device may allow more donor hearts to be used, especially those that would otherwise be rejected for cold storage.

What this could mean

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

Active substance
OCS Heart System (device for preserving donor hearts outside the body)
What this could lead to
If successful, this registry could confirm that the OCS Heart System helps more donor hearts be safely used for transplant, potentially saving more lives.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the device is better than standard cold storage. Results may not apply to all transplant centers.

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 350 people

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

Started

Sep 2021

Expected to finish

Dec 2029

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

Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.

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: * Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System. Recipient Exclusion Criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant. Donor Exclusion Criteria (for DCD Donor Hearts only): * Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).

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Conditions

The condition(s) this trial relates to.

heart failure transplant rejection

As listed by the trial registrant

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

Transplant

Contacts and locations

Locations

  • Baylor Scott and White

    Dallas, Texas, 75226, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cedars Sinai

    Los Angeles, California, 90048, United States

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Medical City Dallas

    Dallas, Texas, 75230, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Montefiore

    The Bronx, New York, 10467, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55414, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington Medical Center

    Seattle, Washington, 98105, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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