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Beating heart machine tested in transplant study

NCT ID NCT03687723

Knowledge-focused Sponsor: Hannover Medical School 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how well a device called the Organ Care System (OCS) works for preserving donor hearts before transplantation. The OCS keeps the heart in a near-natural, beating state instead of on ice. Researchers followed 93 heart transplant recipients for 12 months to see how many survived. The goal was to gather real-world data on the device's use and outcomes.

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 could confirm that the OCS device is a safe and effective way to preserve donor hearts, potentially increasing the number of usable hearts for transplant.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the device is better than standard cold storage. Results may not apply to all transplant centers or donor types.

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

93 people

The number who actually took part.

Started

Oct 2016

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 requiring heart transplantation who receive OCS™-preserved heart transplants.

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: All recipients of heart transplantation with Use of the OCS™ Heart Exclusion Criteria: Donor Hearts * Presence of coronary heart diseases * acute myocardial infarction * Presence of heart valve disease (Stenosis or Insufficiency \> first degree) * Presence of left ventricular hypertrophy (septum and posterior wall thickness \>1.7 cm) * State of shock of donor (MAP \<60 mmHg, CVP \>15, PCWP \>15 mmHg) with use of Dobutamine \>10 ug/kg/min and/or Norepinephrine \> 0.5 ug/kg/min or Epinephrine \> 0.2 ug/kg/min * irreversible persistant pulmonary hypertrophy, defined as transpulmonary gradient \>15 mmHg of the recipient

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Conditions

The condition(s) this trial relates to.

advanced heart failure

As listed by the trial registrant

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

Heart transplantation

Contacts and locations

Locations

  • Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

    Hanover, Germany

More trials for these conditions

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