An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) and Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS) in Premature Ventricular Complexes, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
This prospective, randomized controlled trial aims to evaluate the efficacy and safety of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) for patients with frequent premature ventricular coomplexes (FPVCs). Ninety participants will be randomized to TAVNS group and sham-TAVNS group with the ratio of 1:1. They will receive TAVNS plus usual care or sham-TAVNS plus usual care for 6 weeks, and then be followed up for 12 weeks after the treatment. The primary outcome was the proportion of participants with a 50% decrease of the 24 hour (24h) premature ventricular complexes (PVCs) after 6-week treatment. Secondary outcomes include the proportion of participants with a 75% decrease of the 24h-PVCs; the decrease from baseline of 24h-PVCs, total 24h-heartbeat, and the frequency of supraventricular arrhythmia; the score change from baseline in PVCs-related symptoms; the score change from baseline in SAS and SDS. Subgroup analyses will be performed in age, gender, and the severity of PVCs. Safety assessment will be documented during the whole trial.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's planned enrollment of 90 is close to the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 137 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs.
Device: Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
Sham-TAVNS on Erzhong and Xin (Auricular Acupuncture Point); the same acupoints as the treatment group without any current. Usual Care: usual medicine treatment for PVCs.
Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)
Patients in TAVNS group will receive TAVNS and usual care. TAVNS will be performed on Erzhong and Xin (Auricular Acupuncture Point with vagus nerve distribution) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.
Patients in sham-TAVNS group will receive sham-TAVNS and usual care. Sham-TAVNS will be also performed on Erzhong and Xin (Auricular Acupuncture Point with vegas nerve stimulation) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.
the proportion of participants with a 50% decrease of PVCs from baseline
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6 (at the end of the treatment), then we will obtain the proportion of patients with a 50% decrease.
Time frame: week 6
the proportion of participants with a 50% decrease of PVCs from baseline
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 18 (at the end of the follow-up period), then we will obtain the proportion of patients with a 50% decrease.
Time frame: week 18
the proportion of participants with a 75% decrease of PVCs from baseline
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18, then we will obtain the proportion of patients with a 75% decrease.
Time frame: week 6, week 18
the change from baseline in PVCs
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18.
Time frame: week 6, week 18
the change from baseline in total cardiac impulse
The total cardiac impulse will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of total cardiac impulse between baseline and week 6/18.
Time frame: week 6, week 18
the change from baseline in supraventricular premature contractions
The change from baseline in supraventricular premature contractions will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of supraventricular premature contractions between baseline and week 6/18.
Time frame: week 6, week 18
the score change from baseline in the symptom of palpitation
The symptom of palpitation will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of palpitation. The investigators will calculate the score change of palpitation between baseline and week 6/18.
Time frame: week 6, week 18.
the score change from baseline in the symptom of chest tightness
The symptom of chest tightness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of chest tightness. The investigators will calculate the score change of chest tightness between baseline and week 6/18.
Time frame: week 6, week 18.
the score change from baseline in the symptom of dizziness
The symptom of dizziness will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of dizziness. The investigators will calculate the score change of dizziness between baseline and week 6/18.
Time frame: week 6, week 18.
the score change from baseline in the symptom of insomnia
The symptom of insomnia will be assessed by a 10-scale VAS from 0 to 10, a higher score indicates a more severe symptom of insomnia. The investigators will calculate the score change of insomnia between baseline and week 6/18.
Time frame: week 6, week 18.
the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline
The symptom of palpitation/chest tightness/dizziness/insomnia will be assessed by a 10-scale VAS from 0 to 10. Score 4-6 are defined as the moderate level, Score 7-10 are defined as the severe level. The investigators will calculate the change of the proportion of patients with the moderate/severe symptoms between baseline and week 6/18.
Time frame: week 6, week 18.
the score change from baseline in the SAS
Self Anxiety Scale (SAS) contains 20 items scored from 25 to 100. Score 50-59 was classified as mild anxiety; Score 60-69 as moderate anxiety, and score ≥ 70 as severe anxiety.
Time frame: week 6, week 18.
the score change from baseline in the SDS
Self Depression Scale (SDS) contains 20 items scored from 25 to 100. Score 53-62 was classified as mild depression; Score 63-72 as moderate depression, and score ≥ 73 as severe depression.
Time frame: week 6, week 18.
the score change from baseline in SF-36
The SF-36 questionnaire contains eight scales with two measures: physical and mental health. The physical health includes four scales of physical functioning (PF), role-physical (RF), bodily pain (BP), and general health (GH). The mental health is composed of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). SF-36 scores from 0 to 100, higher scores indicate better health status.
Time frame: week 6, week 18.
subgroup analysis of ages
Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by age: ≤40 years and \> 40 years.
Time frame: week 6
subgroup analysis of gender
Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by gender: male and female.
Time frame: week 6
subgroup analysis of the severity of PVCs
Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with three subgroups by the severity of PVCs through Lown: level 2, level 3, and level 4A
Time frame: week 6
the proportion of participants with adverse events
Safety assessment, The investigators will calculate the adverse events during the whole study.
Time frame: week 6, week 18
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