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Ear stimulation may calm heart inflammation after ablation

NCT ID NCT07633431

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a non-invasive ear stimulation, called low-level tragus stimulation, can reduce inflammation and early heart rhythm problems after pulsed field ablation for atrial fibrillation. Forty-six adults with atrial fibrillation will receive either active or sham stimulation after their procedure. Researchers will measure inflammatory markers and monitor heart rhythm for three months to see if the stimulation helps.

What this could mean

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

Active substance
Low-level tragus stimulation (a non-invasive nerve stimulation device applied to the outer ear)
What this could lead to
If it works, this could offer a simple, non-drug way to reduce inflammation and prevent early heart rhythm problems after a common procedure for atrial fibrillation.
What could go wrong
This is a small, early-stage study with only 46 participants, so results may not apply to everyone. The effect on long-term outcomes is unknown, and the stimulation may not reduce inflammation or arrhythmias as hoped.

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 46 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 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. Age 18 to 80 years, inclusive. 2. Diagnosed with paroxysmal or persistent atrial fibrillation by electrocardiogram or ambulatory electrocardiogram, and scheduled to undergo first catheter ablation for atrial fibrillation. 3. Able to understand and sign the written informed consent form, and willing to participate in this study. 4. Willing and able to comply with the follow-up requirements specified in the study protocol. Exclusion Criteria: 1. History of two or more previous catheter ablation procedures for atrial fibrillation. 2. Scheduled to undergo concomitant cardiac surgery or other interventional procedures during the index procedure. 3. History of cervical vagus nerve injury, abnormal ear anatomy, skin lesions, or other conditions that may prevent correct placement or tolerance of the auricular vagus nerve stimulation electrode. 4. Left ventricular ejection fraction less than 40%. 5. New York Heart Association functional class III or IV. 6. Severe hepatic or renal dysfunction, defined as alanine aminotransferase or aspartate aminotransferase greater than two times the upper limit of normal, or estimated glomerular filtration rate less than 30 mL/min/1.73 m². 7. Known inflammatory disease, connective tissue disease, active infection, or long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs, or immunosuppressive agents for more than 4 weeks. 8. Acute myocardial infarction or unstable angina within 3 months before enrollment. 9. Percutaneous coronary intervention or coronary artery bypass grafting within 3 months before enrollment. 10. Stroke or transient ischemic attack within 3 months before enrollment. 11. Severe uncontrolled hypertension, defined as resting systolic blood pressure of 180 mmHg or higher, or resting diastolic blood pressure of 110 mmHg or higher. 12. Sick sinus syndrome, second-degree type II atrioventricular block, or third-degree atrioventricular block without implantation of a permanent pacemaker. 13. Pregnancy, lactation, or planned pregnancy during the study period. 14. Participation in another drug or medical device clinical trial within 3 months before enrollment. 15. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study, such as expected survival less than 1 year or poor compliance.

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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.

  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000, China

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