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Heart transplant breakthrough? OCS device Follow-Up study tracks 5-Year survival

NCT ID NCT05741723

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 276 heart transplant patients who received a donor heart preserved with the OCS Heart device. Researchers will track survival and other outcomes for up to 5 years after transplant. The goal is to confirm the long-term safety and effectiveness of using OCS-preserved hearts for transplantation.

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 device (preserves donor hearts for transplant)
What this could lead to
If successful, this study could confirm that OCS-preserved hearts are safe and effective for transplantation, potentially increasing the donor heart supply.
What could go wrong
This is a follow-up study, not a new treatment test. It only observes outcomes in already transplanted patients, so it cannot prove new benefits or safety beyond what is already known.

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 276 people

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

Started

Nov 2019

Expected to finish

Oct 2026

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

Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP will comprise the patient population for this PAS.

Ages

18 years and older

Sex

Anyone

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: * Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.

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As listed by the trial registrant

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

Heart transplant

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, 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

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Montefiore

    The Bronx, New York, 10467, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • Nyph/Cumc

    New York, New York, 10032, United States

  • Sentara

    Norfolk, Virginia, 23502, United States

  • St. Vincent Cardiovascular Research Institute

    Indianapolis, Indiana, 46260, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University of California San Diago

    La Jolla, California, 92037, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55414, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

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