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

NCT07633431 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-06-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Low-Level Tragus Stimulation

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.

DEVICE

Sham Low-Level Tragus Stimulation

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.

Sponsors & Collaborators

  • Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Hongtao Wang · Second Affiliated Hospital of Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-08-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633431 on ClinicalTrials.gov