Actively Recruiting
TAES for FPVCs: a Pragmatic, Randomized Controlled Trial
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-07-20
90
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
Sponsors
G
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor
C
China Association for Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
TAES for FPVCs: a Pragmatic, Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed as frequent premature ventricular contractions
- Lown level between 2 and 4A
- Age between 18 and 75 years
- Willing to participate voluntarily
You will not qualify if you...
- Severe valvular disease, congenital heart disease, pericardial disease, hypertrophic cardiomyopathy, unstable angina, acute myocardial infarction, myocarditis, aneurysm, decompensated congestive heart failure (NYHA grade III or VI), cardiogenic shock, cerebrovascular disease, hematopoietic system disease, severe mental illness
- Bradycardia including pathological sinus node syndrome or degree II or greater atrioventricular block
- Have or plan to have a pacemaker or percutaneous coronary intervention
- Pregnant or lactating women
- Local sensory deficit or allergy to electrical current
- Possible allergy to percutaneous patches
- Blood pressure less than or equal to 90/60 mmHg
- Participation in other clinical trials within the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
J
Jiani Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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