NCT04415203

TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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	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.

Timeline

• Start date: 2020-06-04
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-06-04
• Last updated: 2025-07-20

Locations

1 site across 1 country: China