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TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 20, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Jun 2024 to Dec 2025v5
  2. Primary and study completion dates: Dec 2021 to Jun 2024
    • Interventions: Sham Transcutaneous acupoint electrical stimulation (Sham-TAES) (Device), Transcutaneous acupoint electrical stimulation (TAES) (Device) to Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS) (Device), Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)…
    v4
  3. Primary completion date: Jul 2021 to Dec 2021v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2020 to Jun 4, 2020
    • Secondary endpoints: details revised at 10 of 13 entries
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04415203
Lead Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: China Association for Science and Technology
Conditions
(from sponsor)		 Premature Ventricular Complexes
Related terms Ventricular Premature Complexes
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov