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Freezing heart tissue during surgery could stop atrial fibrillation

NCT ID NCT06557616

Disease control Sponsor: Medinice S.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a device called CoolCryo that freezes small areas of heart tissue to stop atrial fibrillation (an irregular heartbeat). It is being used in 20 people who are already having mitral valve surgery. The goal is to see if the freezing treatment can keep the heart in normal rhythm for at least 6 months without serious side effects.

What this could mean

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

Active substance
CoolCryo system (cryoablation device)
What this could lead to
If it works, this could offer a safe way to eliminate atrial fibrillation during mitral valve surgery, reducing stroke and heart failure risk.
What could go wrong
This is a small, early-stage trial with only 20 people, so results may not apply to everyone. Cryoablation carries risks like heart tissue damage or irregular heartbeat.

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 20 people

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

Started

Jul 2024

Expected to finish

Jun 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

Sixteen patients, male and female, aged ≥18 years, qualified for mitral heart valve surgery with documented (in at least one ECG recording) co-occurrence of paroxysmal or persistent atrial fibrillation (AF) will undergo the procedure with the medical device. There is also a prediction of 10 per cent of patients (screen failure) who do not meet the inclusion and/or exclusion criteria after signing informed consent. Additionally, there may be perioperative situations where the cryoablation procedure is not performed due to potential acute aortic dissection or undiagnosed conditions necessitating a change in surgical tactics (e.g. pericarditis). It is estimated that the above situation may affect 1-2 study participants who will be given drop-out status.

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. Written consent from the patient to participate in the study. 2. age ≥18 years. 3. patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement "with" or "without" left atrial appendage closure). 4. a documented diagnosis of co-occurrence of paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery with exclusion of acute conditions. Exclusion Criteria: 1. Lack of written consent from the patient to participate in the study. 2. Failure to meet the inclusion criteria. 3. Contraindications to the cryoablation procedure. 4. Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment. 5. co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia). 6. significant calcification of the left atrium. 7. Condition after previous cardiac surgery. 8. significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection). 9. the patient is currently a participant in another clinical trial. 10. The patient is on active biological therapy. 11. emergency surgery. 12. Life expectancy \<12 months. 13. Any circumstances that, in the opinion of the Investigator, may prevent the patient from participating in the study, limit the ability to perform the procedures outlined in the study protocol or place an unreasonable risk on the patient.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation mitral valve disorder

As listed by the trial registrant

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

Atrial fibrillation, paroxysmal or persistent Mitral valve disease

How to take part

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

  1. The places running it

    2 sites. 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

  • Antoni Jurasz University Hospital No. 1

    RECRUITING

    Bydgoszcz, 85-094, Poland

  • Silesian Centre for Heart Diseases

    RECRUITING

    Zabrze, 41-800, Poland

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