TAES for FPVCs: a Pragmatic Randomized Controlled Trial

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    90
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Updated on 13 August 2021

Summary

This prospective, pragmatic, randomized controlled trial aims to evaluate the efficacy and safety of transcutaneous acupoint electrical stimulation (TAES) for patients with frequent premature ventricular contractions (FPVCs). Ninety participants will be randomized to TAES group and sham-TAES group with the ratio of 1:1. They will receive TAES plus usual care or sham-TAES 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 contractions (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.

Details
Condition Premature ventricular contractions, ventricular extrasystoles
Treatment Transcutaneous acupoint electrical stimulation (TAES), Sham Transcutaneous acupoint electrical stimulation (Sham-TAES)
Clinical Study IdentifierNCT04415203
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on13 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed as frequent premature ventricular contractions
Lown level 4A
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
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