NCT07633431Active, not recruiting
The Effect of Low-Level Tragus Stimulation on Inflammation and Early Recurrence After Pulsed Field Ablation: A Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 30 May 2026
- Start date
- 11 Jun 2026
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Xi'an Jiaotong University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07633431
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 11 Jun 2026 to the primary completion date, 30 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Participation in another drug or medical device clinical trial within 3 months before enrollment.
Other illness
- 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.
- New York Heart Association functional class III or IV.
- 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.
- 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.
- 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.
Lab values
- Left ventricular ejection fraction less than 40%.
Other
- 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.
- Pregnancy, lactation, or planned pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.