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.
Diagnosed as frequent premature ventricular contractions;
2 ≤ Lown level ≤ 4A;
18 ≤ age ≤ 75;
Volunteered to participant
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;
Parallel
Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
DevicePatients in TAVNS group will receive TAVNS and usual care. TAVNS will be performed on Erzhong and Xin (Auricular Acupuncture Point with vagus nerve distribution) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.
Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)
DevicePatients in sham-TAVNS group will receive sham-TAVNS and usual care. Sham-TAVNS will be also performed on Erzhong and Xin (Auricular Acupuncture Point with vegas nerve stimulation) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.
the proportion of participants with a 50% decrease of PVCs from baseline
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6 (at the end of the treatment), then we will obtain the proportion of patients with a 50% decrease.
the proportion of participants with a 50% decrease of PVCs from baseline
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 18 (at the end of the follow-up period), then we will obtain the proportion of patients with a 50% decrease.
the proportion of participants with a 75% decrease of PVCs from baseline
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18, then we will obtain the proportion of patients with a 75% decrease.
the change from baseline in PVCs
The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6/18.
the change from baseline in total cardiac impulse
The total cardiac impulse will be assessed by a 24-hour Holter monitoring. The investigators will calculate the change of total cardiac impulse between baseline and week 6/18.
subgroup analysis of ages
Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by age: ≤40 years and \> 40 years.
subgroup analysis of gender
Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with two subgroups by gender: male and female.
subgroup analysis of the severity of PVCs
Subgroup analysis will be performed in the primary outcome. The investigators will classify the patients with three subgroups by the severity of PVCs through Lown: level 2, level 3, and level 4A
the proportion of participants with adverse events
Safety assessment, The investigators will calculate the adverse events during the whole study.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
China Association for Science and Technology
Collaborator
