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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Diagnosed as frequent premature ventricular contractions;

• 2 ≤ Lown level ≤ 4A;

• 18 ≤ age ≤ 75;

• Volunteered to participant

Locations
Other Locations
China
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Jiani Wu
jiani_wu@aliyun.com
+8613426116653
Time Frame
Start Date: 2020-06-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 90
Treatments
Experimental: TAVNS plus usual care
TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: China Association for Science and Technology

This content was sourced from clinicaltrials.gov