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New device aims to filter out dangerous inflammation during heart surgery

NCT ID NCT06512623

Disease control Sponsor: Centre Hospitalier Universitaire Vaudois 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called HA-380® that filters inflammatory substances from the blood during heart-lung bypass in complex cardiac surgeries. Forty-one adults undergoing high-risk procedures like heart transplants or aortic dissection repairs were enrolled. The goal was to see if the device could reduce organ failure and improve recovery.

What this could mean

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

Active substance
Hemoadsorption device (HA-380® cartridge)
What this could lead to
If effective, this device could reduce inflammation-related organ failure after complex heart surgery, potentially shortening hospital stays and improving survival.
What could go wrong
This is a small, single-center trial with only 41 patients, so results may not apply broadly. The device may not show clear benefit over standard care.

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

41 people

The number who actually took part.

Started

Oct 2024

Finished

Jan 2026

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 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: 1. Adults (≥18 years old at study inclusion) 2. Planned for one of the following cardiac surgical procedures: heart transplantation after L-VAD (left ventricular assist device) implantation, OR surgical repair of a type A aortic dissection, OR urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, OR cardiac surgery likely to require \>180 min CPB time as estimated by the surgical team 3. Signed informed consent Exclusion Criteria: 1. Indication to receive hemoadsorption during CPB for drugs removal 2. Women who are pregnant or breastfeeding 3. Previous enrolment into the current study 4. Off-pump procedure 5. Chronic immunosuppression 6. Known allergy to heparin or heparin induced thrombocytopenia 7. Severe thrombopenia (platelets count before surgery \< 20g/L) 8. Patient who does not want to be informed of incidental findings 9. Participation in another study with investigational drug within the 30 days preceding and during the present study 10. Participation in another conflicting research study

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Conditions

The condition(s) this trial relates to.

heart disorder infective endocarditis Inflammation inflammatory disease multiple organ dysfunction syndrome

As listed by the trial registrant

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

Cardiac disease Cardio-pulmonary bypass Inflammation Organ dysfunction syndrome Post-cardiac surgery

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011, Switzerland

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