NCT07633431

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
18mo left

Started Jun 2026

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

May 30, 2026

Last Update Submit

June 3, 2026

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 24 hours after pulsed field ablation

Secondary Outcomes (1)

  • Documented Early Atrial Arrhythmia Events Within 3 Months After Pulsed Field Ablation

    From the end of pulsed field ablation to 3 months after the procedure

Study Arms (2)

Low-Level Tragus Stimulation

EXPERIMENTAL

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.

Device: Low-Level Tragus Stimulation

Sham Stimulation

SHAM COMPARATOR

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.

Device: Sham Low-Level Tragus Stimulation

Interventions

Low-Level Tragus StimulationDEVICE

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.

Low-Level Tragus Stimulation
Sham Low-Level Tragus StimulationDEVICE

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.

Sham Stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.
  • New York Heart Association functional class III or IV.
  • 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.
  • 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.
  • Acute myocardial infarction or unstable angina within 3 months before enrollment.
  • Percutaneous coronary intervention or coronary artery bypass grafting within 3 months before enrollment.
  • Stroke or transient ischemic attack within 3 months before enrollment.
  • Severe uncontrolled hypertension, defined as resting systolic blood pressure of 180 mmHg or higher, or resting diastolic blood pressure of 110 mmHg or higher.
  • Sick sinus syndrome, second-degree type II atrioventricular block, or third-degree atrioventricular block without implantation of a permanent pacemaker.
  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Participation in another drug or medical device clinical trial within 3 months before enrollment.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hongtao Wang

    Second Affiliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongtao Wang

CONTACT

+86-13891944803Wht506@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants, outcome assessors, and statisticians will be blinded to treatment allocation. Due to the nature of the stimulation intervention, the personnel responsible for delivering low-level tragus stimulation or sham stimulation will not be blinded. Participants will be randomly assigned after pulsed field ablation to either the active low-level tragus stimulation group or the sham stimulation group. To maintain blinding, the devices used in both groups will have the same appearance and the same operating procedures. Participants will be informed that the sensation of stimulation may vary among individuals and that both the presence and absence of sensation may be normal.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized after pulsed field ablation into two parallel groups: low-level tragus stimulation group and a sham stimulation group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 8, 2026

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with external researchers. This is a small, single-center exploratory clinical trial, and the approved informed consent documents do not include a plan for public or external sharing of participant-level data. To protect participant privacy and confidentiality, study data will be analyzed and reported only in aggregate form. Study findings may be disseminated through academic publications or presentations without disclosure of identifiable information or individual participant-level data.

Locations

CN(1)