TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

G

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Enrolling

Conditions

Premature Ventricular Complexes

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04415203
TAESforFPVC

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

TAVNS plus usual care
Experimental group
Description:
TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs.
Treatment:
Device: Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
Sham-TAVNS plus usual care
Placebo Comparator group
Description:
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.
Treatment:
Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)

Trial contacts and locations

0

Loading...

Central trial contact

Jiani Wu

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems