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New heart surgery technique aims to stop AFib in its tracks

NCT ID NCT07312149

Disease control Sponsor: Nantes University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new technique called PWI-Box, which uses a device named GeminiS to isolate the pulmonary veins and treat atrial fibrillation (AF) during open-heart surgery. About 200 adults with AF who are already scheduled for heart surgery via sternotomy will take part. The main goal is to see if this approach reduces AF recurrence one year after surgery, as measured by a 24-hour heart monitor.

What this could mean

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

Active substance
GeminiS device for pulmonary vein isolation with posterior wall isolation (PWI-Box)
What this could lead to
If successful, this could offer a simpler, more reproducible way to treat atrial fibrillation during open-heart surgery, potentially reducing AF recurrence and stroke risk.
What could go wrong
This is an early-stage study (not yet recruiting) with 200 participants. The technique may not work as well as hoped, and surgery carries standard risks like infection or bleeding.

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 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2032

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.

Who is studied

Patients with a surgical indication for AF in combination with conventional cardiac surgery performed by sternotomy (coronary artery bypass grafting, aortic valve replacement, aortic surgery, etc.). Patients may be included prospectively, via information provided by the attending physician during a consultation (written and oral), or retrospectively for those who have already undergone surgery, by sending an information notice with a non-objection period.

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: * Patients undergoing cardiac surgery via sternotomy * Concomitant use of the PWI box with GeminiS during surgery * Adult patients * Patients with the following characteristics: Preoperative paroxysmal/persistent/permanent AF; Duration of less than 5 years; And left atrium volume \<60 ml/m2 * Informed patient who did not object to the collection of their data for the study Exclusion criteria: * Unplanned surgery (emergency) * History of cardiac surgery (reoperation) * Pregnant or breastfeeding women * Adults under guardianship, curatorship or judicial protection * Patients with a life expectancy of less than three years * Patients currently taking medication or using an experimental device that clinically interferes with the study's evaluation criteria and results. * Inability to comply with the monitoring schedule. * Contraindication to long-term anticoagulants

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF) Cardiac surgery

How to take part

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

  1. The places running it

    1 site. 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

  • CHU de Nantes

    Nantes, 44093, France

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