TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

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

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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)