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Zapping a nerve in the ear may stop heart surgery complication

NCT ID NCT04514757

Prevention Sponsor: University of California, Los Angeles 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers are testing whether stimulating a nerve in the ear can prevent atrial fibrillation, a common irregular heartbeat, after heart surgery. The study includes adults scheduled for heart bypass, valve, or major vascular surgery. Participants receive either active stimulation or a sham treatment twice daily for up to five days after surgery. The goal is to see if this approach reduces the number of atrial fibrillation episodes and shortens hospital stays.

What this could mean

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

Active substance
transcutaneous tragus vagal nerve stimulation
What this could lead to
If it works, this could offer a non-invasive way to prevent atrial fibrillation after heart surgery and shorten hospital stays.
What could go wrong
The trial is small and early, so results may not hold up in larger studies. The stimulation may not prevent atrial fibrillation or may cause discomfort.

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

77 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2024

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 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: 1. Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons. 2. Age ≥ 18 years. 3. Sinus rhythm at baseline. 4. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study Exclusion Criteria: 1. Emergent surgery 2. Anticipated amiodarone use 3. Patients with permanent or persistent atrial fibrillation 4. Planned concomitant atrial Maze procedure 5. Complex congenital heart disease 6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal). 7. Left ventricular assist device or status post orthotopic heart or lung transplantation 8. Unable or unwilling to comply with protocol requirements. 9. Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia 10. Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker. 11. Complete heart block or trifascicular block without an implantable pacemaker 12. Recurrent vasovagal syncope 13. Unilateral or bilateral vagotomy 14. Chronic amiodarone use

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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

Contacts and locations

Locations

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

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