Using Transcutaneous Auricular Vagus Nerve Stimulation for treating frequent premature ventricular complexes
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04415203 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with frequent premature ventricular contractions.
Not a fit: Patients with severe heart conditions, significant comorbidities, or those who are pregnant or lactating may not benefit from this study.
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 performed: While the approach of using TAVNS is innovative, similar studies have shown promise in the use of vagus nerve stimulation for various cardiac conditions.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.