Using Transcutaneous Auricular Vagus Nerve Stimulation for treating frequent premature ventricular complexes
Official title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
Run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · NCT04415203 · Data updated 2026-11-12
This study is testing if a new treatment using electrical stimulation of the ear can help people with frequent heart palpitations feel better and reduce their symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 4, 2020 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | July 20, 2025 |
| Trial ID | NCT04415203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 diagnosed with frequent premature ventricular contractions.
✕Probably not a fit
Patients with severe heart conditions, significant comorbidities, or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) in patients experiencing frequent premature ventricular complexes (FPVCs). Ninety participants will be randomly assigned to receive either TAVNS combined with usual care or a sham-TAVNS treatment alongside usual care for a duration of six weeks. The primary outcome is the proportion of participants achieving a 50% reduction in 24-hour PVCs after treatment, with secondary outcomes assessing further reductions and symptom changes. Follow-up will occur for 12 weeks post-treatment to monitor ongoing effects.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of PVCs and improve the quality of life for patients suffering from this condition.
How similar studies have gone: While the approach of using TAVNS is innovative, similar studies have shown promise in the use of vagus nerve stimulation for various cardiac conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed as frequent premature ventricular contractions; * 2 ≤ Lown level ≤ 4A; * 18 ≤ age ≤ 75; * Volunteered to participant Exclusion Criteria: * Severe valvular disease, congenital heart disease, pericardial disease, hypertrophic cardiomyopathy, unstable angina pectoris, acute myocardial infarction, myocarditis, aneurysm, congestive heart failure decompensation period (NYHA grade III or VI), cardiogenic shock, cerebrovascular disease, hematopoietic system disease, severe mental disease; * Bradycardia, including pathologic sinus node syndrome, degree II or greater atrioventricular block; * Those who have already had pacemaker or percutaneous coronary intervention, or who plan to have pacemaker or percutaneous coronary intervention; * Pregnant or lactating women; * Local sensory deficit, or allergic to current; * May be allergic to percutaneous patches; * Blood pressure ≤ 90/60 mmHg; * Those who have participated in other clinical trials within 3 months.
Where it's running
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Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Jiani Wu — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study coordinator: Jiani Wu
- Email: jiani_wu@aliyun.com
- Phone: +8613426116653
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Severe Complications During VT/PVC Ablation
This study looks at real-world cases to see what severe complications occur during VT or PVC ablations and how patients are managed afterward.
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Catheter ablation vs. anti-arrhythmic drugs for PVCs
This study tests whether catheter ablation or anti-arrhythmic medications are better at reducing PVC symptoms and improving quality of life for adults with a normal heart function.
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Impact of Premature Ventricular Complexes on Respiratory and Physical Health
This study tests how premature ventricular complexes affect breathing, respiratory and hand strength, cough, physical activity, and quality of life in adults with PVCs compared with healthy controls.
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Using flecainide to treat frequent premature ventricular contractions and related heart issues
This study is testing if the heart medication flecainide can help adults with frequent heartbeats and related heart issues who can't or don't want to have a procedure called catheter ablation.
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Evaluating the need for cardiac MRI in patients with premature ventricular complexes
This study is trying to see if heart scans are really needed for people with premature ventricular complexes to find any hidden heart problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.