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

Sponsor
Xi'an Jiaotong University
Study ID
NCT07633431
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Level Tragus Stimulation — DEVICE
    Low-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 — DEVICE
    Sham 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.

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Aug 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Level Tragus Stimulation
    Participants in this arm will receive active low-level tragus stimulation after pulsed field ablation. The stimulation will be delivered to the tragus region according to the study protocol.
  • Sham Comparator: Sham Stimulation
    Participants in this arm will receive sham stimulation after pulsed field ablation. The sham stimulation procedure will use a device with the same appearance and operating procedures as the active stimulation device, but without effective electrical current output.

Primary Outcome Measure

Change in Serum Inflammatory Marker Levels From Baseline to 24 Hours After Pulsed Field Ablation [ Time Frame: Baseline and 24 hours after pulsed field ablation ]

Central Contacts

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