Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New heart device aims to fix irregular rhythm during surgery

NCT ID NCT07410962

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a new device that uses pulsed electric fields to treat atrial fibrillation (an irregular heartbeat) during planned heart surgery. Sixteen adults will receive the treatment and be followed for 6 months to check safety and whether the heart rhythm stays normal. The goal is to see if this approach is safe and works well enough for larger studies.

What this could mean

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

Active substance
Cardiac pulsed field ablation device and disposable electrode
What this could lead to
If successful, this could offer a safer, more precise way to treat atrial fibrillation during heart surgery, potentially reducing complications.
What could go wrong
This is a very early, small trial with only 16 people. The device may not work as hoped, and risks include serious bleeding, stroke, or heart attack.

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 16 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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 80 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: * Subjects aged ≥ 18 years and ≤ 80 years; * Subjects are willing and able to sign the informed consent form to receive study treatment, including surgical atrial fibrillation ablation, and complete the follow-up specified in the clinical study protocol; * Subjects with a history, electrocardiogram, or Holter ECG confirming paroxysmal atrial fibrillation, persistent atrial fibrillation (lasting more than seven days, or less than seven days but requiring drug or electrical cardioversion), or long-standing persistent atrial fibrillation (lasting more than one year); * Left ventricular ejection fraction \> 30% (determined by echocardiography or cardiac catheterization within 60 days prior to enrollment, as recorded in the patient's medical history); * Subjects scheduled to undergo open-heart surgery, including one or more of the following cardiac surgeries performed under direct vision: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, and coronary artery bypass grafting; * Subjects with an expected survival of ≥ 1 year. Exclusion Criteria: * Subjects with implanted electronic medical devices (such as pacemakers, ICDs, or CRT) or left atrial appendage devices; * Subjects with artificial heart valves; * Subjects with atrial fibrillation only, without indications for coronary artery bypass grafting (CABG) and/or valve surgery; * History of previous atrial fibrillation ablation, atrioventricular (AV) node ablation, or Maze procedure; * History of previous cardiac surgery (reoperation); * Wolff-Parkinson-White (WPW) syndrome or other supraventricular arrhythmias, AV nodal reentry, ventricular arrhythmias requiring antiarrhythmic drug treatment, or uncontrolled bradyarrhythmias (sinus bradycardia, junctional rhythm, ventricular escape rhythm, sinus arrest, sinoatrial block, second-degree AV block, third-degree AV block, and sick sinus syndrome).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atrial fibrillation fluttering are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. 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 ↗

  2. 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.