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Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?

NCT ID NCT07824492

Prevention Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether mild electrical stimulation of a nerve in the ear can prevent atrial fibrillation, a common irregular heartbeat, after off-pump coronary artery bypass surgery. Adults scheduled for this heart surgery receive either the stimulation plus standard care or standard care alone. The trial measures how many people develop atrial fibrillation within seven days after surgery, along with inflammation markers, heart rate variability, and safety.

What this could mean

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

Active substance
transcutaneous auricular vagus nerve stimulation, a noninvasive device that delivers mild electrical pulses to the ear
What this could lead to
If it works, this could offer a drug-free, noninvasive way to lower the risk of irregular heartbeats after heart bypass surgery.
What could go wrong
The approach is still experimental, and it may not reduce atrial fibrillation after surgery. Some participants may find the ear stimulation uncomfortable, and results from this single-center trial may not apply everywhere.

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 410 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 2027

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.

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. Age 18 years or older. 2. Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease. 3. Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias. 4. Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures. 5. Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring. Exclusion Criteria: 1. History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy. 2. Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting. 3. Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures. 4. Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator. 5. Severe comorbidities, including severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²), active malignancy, current immunosuppressive therapy, or chronic inflammatory disease. 6. Inability to tolerate auricular stimulation, including significant skin allergy or intolerance, or anticipated poor adherence to the study procedures. 7. Expected survival of less than 12 months or inability to complete follow-up.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation (AF) OPCABG

How to take part

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  1. The official record

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