New heart device aims to fix irregular rhythm during surgery
NCT ID NCT07410962
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
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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
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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).
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.