TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

Official title

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial

Overview

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.

Interventions

• Device Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
  Patients 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.
• Device Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)
  Patients 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.

Primary outcome measures

• the proportion of participants with a 50% decrease of PVCs from baseline [Time frame: week 6]

Secondary outcome measures (12)

• the proportion of participants with a 50% decrease of PVCs from baseline [Time frame: week 18]
• the proportion of participants with a 75% decrease of PVCs from baseline [Time frame: week 6, week 18]
• the change from baseline in PVCs [Time frame: week 6, week 18]
• the change from baseline in total cardiac impulse [Time frame: week 6, week 18]
• the change from baseline in supraventricular premature contractions [Time frame: week 6, week 18]
• the score change from baseline in the symptom of palpitation [Time frame: week 6, week 18.]
• the score change from baseline in the symptom of chest tightness [Time frame: week 6, week 18.]
• the score change from baseline in the symptom of dizziness [Time frame: week 6, week 18.]
• the score change from baseline in the symptom of insomnia [Time frame: week 6, week 18.]
• the change of the proportion of participants with moderate/severe symptoms of palpitation, chest tightness, dizziness or insomnia from baseline [Time frame: week 6, week 18.]
• the score change from baseline in the SAS [Time frame: week 6, week 18.]
• the score change from baseline in the SDS [Time frame: week 6, week 18.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Guang'anmen Hospita, China Academy of Chinese Medical Sciences — Beijing

Publications

• Liu Y, Wei X, Wang L, Yang Y, Xu L, Sun T, Yang L, Cai S, Liu X, Qin Z, Bin L, Sun S, Lu Y, Cui J, Liu Z, Wu J. Efficacy and safety of transcutaneous auricular vagus nerve stimulation for frequent premature ventricular complexes: rationale and design of the TASC-V trial. BMC Complement Med Ther. 2024 Jul 29;24(1):288. doi: 10.1186/s12906-024-04568-1. PMID 39075454

Identifiers

NCT: NCT04415203 · TAESforFPVC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗