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Gentler Heart-Lung machine tested in 1,300-Patient trial

NCT ID NCT05487612

Disease control Sponsor: Aristotle University Of Thessaloniki 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares a newer, minimally invasive heart-lung machine (MiECC) to the standard machine used during heart surgery. Researchers want to see if the newer machine reduces serious problems like heart attack, stroke, or kidney injury. About 1,300 adults having elective heart surgery will take part.

What this could mean

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

Active substance
Minimally invasive extracorporeal circulation (MiECC) device
What this could lead to
If successful, this could show that a newer, gentler heart-lung machine reduces serious complications after heart surgery, leading to better recovery.
What could go wrong
This is an early-stage comparison, not a cure. The device may not prove significantly better than the standard approach, and individual results vary.

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

About 1,300 people

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

Started

May 2022

Expected to finish

Mar 2029

An estimate. End dates often move.

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.

Ages

18 to 85 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: * All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest. Exclusion Criteria: * Requirement for emergency or salvage operation. * Requirement for major aortic surgery (e.g. aortic root replacement). * Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products. * Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded). * Inability to give informed consent for the study (e.g. learning or language difficulties).

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis coronary artery disorder

As listed by the trial registrant

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

Aortic valve stenosis Coronary artery disease Extracorporeal circulation; complications

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 4 countries. 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

  • Cardiothoracic Department AHEPA University Hospital

    RECRUITING

    Thessaloniki, 54636, Greece

  • Deparment of Cardiac Surgery, Castle Hill Hospital

    ACTIVE_NOT_RECRUITING

    Hull, HU16 5JQ, United Kingdom

  • Department of Cardiac Surgery

    ACTIVE_NOT_RECRUITING

    Coswig, 06869, Germany

  • Department of Cardiac Surgery GVM Anthea Hospital

    RECRUITING

    Bari, 70124, Italy

  • Department of Cardiac Surgery GVM Maria Eleonora Hospital

    ACTIVE_NOT_RECRUITING

    Palermo, 90135, Italy

  • Department of Cardiac Surgery, Royal Papworth Hospital

    ACTIVE_NOT_RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • Department of Cardiothoracic Surgery, Hammersmith Hospital

    ACTIVE_NOT_RECRUITING

    London, W120HS, United Kingdom

  • Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital

    COMPLETED

    Ulm, 89081, Germany

  • Department of Cardiovascular Surgery, Ankara City Hospital

    ACTIVE_NOT_RECRUITING

    Ankara, Turkey (Türkiye)

  • Department of Cardiovascular Surgery, Faculty of Medicine, Recep Tayyip Erdoğan University

    RECRUITING

    Rize, Turkey (Türkiye)

  • Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine

    RECRUITING

    Izmir, Turkey (Türkiye)

  • Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen

    ACTIVE_NOT_RECRUITING

    Göttingen, Germany

  • Perfusion Services University Health Network, Toronto General Hospital

    RECRUITING

    Toronto, M5G 2C4, Canada

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