Please sign in to follow a disease.
Ear stimulation may calm heart inflammation after ablation
NCT ID NCT07633431
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atrial fibrillation are added.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
Contacts and locations
Locations
-
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?