TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

NCT ID: NCT04415203

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2025-12-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAVNS plus usual care

TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs.

Group Type: EXPERIMENTAL

Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)

Intervention Type: 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-TAVNS plus usual care

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.

Group Type: PLACEBO_COMPARATOR

Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Association for Science and Technology

UNKNOWN

Sponsor Role: collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jiani Wu

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiani Wu

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiani Wu

Role: CONTACT

jiani_wu@aliyun.com

+8613426116653

Facility Contacts

Jiani Wu

Role: primary

+8613426116653

References

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.

Reference Type: DERIVED

PMID: 39075454 (View on PubMed)

Other Identifiers

TAESforFPVC

Identifier Type: -

Identifier Source: org_study_id