Premature Ventricular ComplexesNCT04415203
TAES for FPVCs: a Pragmatic, Randomized Controlled Trial
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) in people with Premature Ventricular Complexes, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Premature Ventricular Complexes
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as frequent premature ventricular contractions;
- 2 ≤ Lown level ≤ 4A;
- 18 ≤ age ≤ 75;
- Volunteered to participant
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Jiani Wu, +8613426116653
About this study
Official title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
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.
- Conditions
- Premature Ventricular Complexes
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)Device
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.
Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| TAVNS plus usual care | Experimental | TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) |
| Sham-TAVNS plus usual care | Placebo comparator | 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. Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 6
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 6, week 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start4 Jun 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ventricular ComplexesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- China Association for Science and Technology
- Responsible party
- Principal investigator, Jiani Wu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiani Wu, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415203
- Sponsor's protocol ID
- TAESforFPVC
- Status last verified
- Jul 2025
- First submitted
- 30 May 2020
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Wei X, Wang L, Yang Y, Xu L, Sun T, Yang L, Cai S, Liu X, Qin Z, Bin L, Sun S, Lu Y, Cui J, Liu Z, Wu J. Efficacy and safety of transcutaneous auricular vagus nerve stimulation for frequent premature ventricular complexes: rationale and design of the TASC-V trial. BMC Complement Med Ther. 2024 Jul 29;24(1):288. doi: 10.1186/s12906-024-04568-1.
PubMed 39075454
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04415203
- Acronym / sponsor ID
- TAESforFPVC
- Conditions
- Premature Ventricular Complexes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- China Association for Science and Technology
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVNS plus usual care | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs. |
| Sham-TAVNS plus usual care | Placebo comparator | Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as frequent premature ventricular contractions;
- 2 ≤ Lown level ≤ 4A;
- 18 ≤ age ≤ 75;
- Volunteered to participant
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (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. | Device | TAVNS plus usual care |
| Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)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. | Device | Sham-TAVNS plus usual care |
Primary outcome
the proportion of participants with a 50% decrease of PVCs from baseline
Time frame: week 6
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.
13 secondary outcomes
the proportion of participants with a 50% decrease of PVCs from baseline
Time frame: week 18
the proportion of participants with a 75% decrease of PVCs from baseline
Time frame: week 6, week 18
the change from baseline in PVCs
Time frame: week 6, week 18
the change from baseline in total cardiac impulse
Time frame: week 6, week 18
the change from baseline in supraventricular premature contractions
Time frame: week 6, week 18
the score change from baseline in the symptom of palpitation
Time frame: week 6, week 18.
the score change from baseline in the symptom of chest tightness
Time frame: week 6, week 18.
the score change from baseline in the symptom of dizziness
Time frame: week 6, week 18.
the score change from baseline in the symptom of insomnia
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
Time frame: week 6, week 18.
the score change from baseline in the SAS
Time frame: week 6, week 18.
the score change from baseline in the SDS
Time frame: week 6, week 18.
the score change from baseline in SF-36
Time frame: week 6, week 18.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 39075454Liu Y, Wei X, Wang L, Yang Y, Xu L, Sun T, Yang L, Cai S, Liu X, Qin Z, Bin L, Sun S, Lu Y, Cui J, Liu Z, Wu J. Efficacy and safety of transcutaneous auricular vagus nerve stimulation for frequent premature ventricular complexes: rationale and design of the TASC-V trial. BMC Complement Med Ther. 2024 Jul 29;24(1):288. doi: 10.1186/s12906-024-04568-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiani Wu principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) in people with Premature Ventricular Complexes, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiani Wu (+8613426116653, jiani_wu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of participants with a 50% decrease of PVCs from baseline (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.