TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

NCT04415203 | Recruiting

• 1 other identifier: TAESforFPVC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  week 6

Secondary Outcomes (13)

• the proportion of participants with a 50% decrease of PVCs from baseline

  week 18

• the proportion of participants with a 75% decrease of PVCs from baseline

  week 6, week 18

• the change from baseline in PVCs

  week 6, week 18

• the change from baseline in total cardiac impulse

  week 6, week 18

• the change from baseline in supraventricular premature contractions

  week 6, week 18

Other Outcomes (4)

• subgroup analysis of ages

  week 6

• subgroup analysis of gender

  week 6

• subgroup analysis of the severity of PVCs

  week 6

Study Arms (2)

TAVNS plus usual care

EXPERIMENTAL

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 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.

Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)

Interventions

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.

TAVNS plus usual care

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.

Sham-TAVNS plus usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as frequent premature ventricular contractions;
• ≤ Lown level ≤ 4A;
• ≤ age ≤ 75;
• Volunteered to participant

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• China Association for Science and Technology: collaborator

Study Sites (1)

Guang'anmen Hospita, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39075454 DERIVED

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiani Wu

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiani Wu

CONTACT

+8613426116653; jiani_wu@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 4, 2020
• Study Start: June 4, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (1)