Atrial fibrillation is a common heart rhythm disorder. Some patients may have early episodes of atrial arrhythmia after pulsed field ablation, and inflammation after the procedure may be related to these early episodes. Low-level tragus stimulation is a non-invasive form of nerve stimulation applied to the outer ear. It may help regulate the autonomic nervous system and inflammatory responses.
This randomized controlled study will evaluate whether low-level tragus stimulation after pulsed field ablation can reduce post-procedural inflammation and early atrial arrhythmia recurrence in patients with atrial fibrillation. Participants who meet the study criteria will be randomly assigned to receive either active low-level tragus stimulation or sham stimulation after the ablation procedure. The study will compare inflammatory markers before and after the procedure, monitor heart rhythm during and after the stimulation period, and assess early atrial arrhythmia recurrence during follow-up.
The investigators hypothesize that low-level tragus stimulation may reduce inflammatory responses after pulsed field ablation and may be associated with fewer early atrial arrhythmia episodes compared with sham stimulation.
Age 18 to 80 years, inclusive.
Diagnosed with paroxysmal or persistent atrial fibrillation by electrocardiogram or ambulatory electrocardiogram, and scheduled to undergo first catheter ablation for atrial fibrillation.
Able to understand and sign the written informed consent form, and willing to participate in this study.
Willing and able to comply with the follow-up requirements specified in the study protocol.
History of two or more previous catheter ablation procedures for atrial fibrillation.
Scheduled to undergo concomitant cardiac surgery or other interventional procedures during the index procedure.
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.
Left ventricular ejection fraction less than 40%.
Parallel
Low-Level Tragus Stimulation
DeviceLow-level tragus stimulation will be delivered after pulsed field ablation according to the study protocol. Electrical stimulation will be applied to the tragus region using the study stimulation device. The intervention will be performed using the prespecified stimulation procedures, timing, and duration described in the protocol.
Sham Low-Level Tragus Stimulation
DeviceSham low-level tragus stimulation will be delivered after pulsed field ablation using a device with the same appearance and operating procedures as the active stimulation device, but without effective electrical current output. The sham procedure will follow the same study schedule and duration as the active stimulation intervention.
Change in Serum Inflammatory Marker Levels From Baseline to 24 Hours After Pulsed Field Ablation
Serum inflammatory markers, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), will be measured in peripheral blood samples collected before pulsed field ablation and 24 hours after the procedure. Changes in IL-6 and TNF-alpha levels from baseline to 24 hours after ablation will be compared between the active low-level tragus stimulation group and the sham stimulation group.
Documented Early Atrial Arrhythmia Events Within 3 Months After Pulsed Field Ablation
Early atrial arrhythmia events will be assessed using post-procedural rhythm monitoring and follow-up evaluations after pulsed field ablation. Rhythm monitoring will cover the entire low-level tragus stimulation treatment period and will continue for at least 12 hours after the procedure. Follow-up evaluations will be performed at 1 month and 3 months after the procedure. Early atrial arrhythmia events include atrial fibrillation, atrial flutter, and atrial tachycardia documented by electrocardiogram, rhythm monitoring, or other clinically available rhythm records.
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