The Effect of Low-Level Tragus Stimulation on Inflammation and Early Recurrence After Pulsed Field Ablation: A Randomized Controlled Study

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.