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Heart transplant breakthrough: keeping donor hearts beating during transport could save more lives

NCT ID NCT03991923

Disease control Sponsor: XVIVO Perfusion 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares a new method of preserving donor hearts (keeping them warm and beating with blood flow) to the standard cold storage method. The goal is to see if the new approach leads to better heart function and fewer complications in the first month and year after transplant. About 230 adult heart transplant recipients will take part across multiple 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.

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

230 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Dec 2028

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 to 70 years

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 recipient: * Age ≥18 years * Signed informed consent form * Listed for heart transplantation Inclusion criteria donor: * Age ≥18 and ≤70 years * Accepted as heart donor by the transplant team * (Research consent from the donor if required in country) Exclusion Criteria recipient: * Previous solid organ transplantation * Grown-up congenital heart disease (GUCH) * Kidney failure eGFR\<40 at listing, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease * Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia * Subject diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis * Known ongoing septicemia defined as positive blood culture immediately prior to the transplant (including with a durable VAD) * Incompatible blood group * Not able to understand the information provided during the informed consent procedure * Combined organ transplantation candidates * Subject already enrolled in another transplant related intervention study * Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery) * Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump) Exclusion criteria donor: * Previous sternotomy * DCD hearts

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As listed by the trial registrant

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

Heart transplantation

Contacts and locations

Locations

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, Austria

  • Azienda osedalaria di Padova

    Padova, Padova PD, 35121, Italy

  • Deutschen Herzzentrum Berlin

    Berlin, Brandenburg, 13353, Germany

  • Freeman Hospital

    Newcastle, Newcastle Upon Tyne, NE77DN, United Kingdom

  • Hannover Medical School

    Hanover, Germany

  • Hospital Puerto de Hierro

    Madrid, Majadahonda Madrid, 28222, Spain

  • Hôpital Bichat Claude-Bernard

    Paris, France

  • Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière

    Paris, Paris Cedex, 75651, France

  • Klinikum der Universität München

    München, Bavaria, 81377, Germany

  • Queen Elisabeth Hospital

    Birmingham, B152TH, United Kingdom

  • Royal Papworth Hospital

    Cambridge, United Kingdom

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götalands Regionen, 412 34, Sweden

  • UZ Leuven

    Leuven, Flemish Brabant, 3000, Belgium

  • Universitätsklinik der Ruhr-Universität Bochum

    Bad Oeynhausen, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

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