NCT06110364

Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized control pilot study

Detailed description

The primary aims of this investigator initiated study is : Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.

Conditions

• Premature Ventricular Contraction

Interventions

Type	Name	Description
DEVICE	Low-Level Tragus Stimulation	Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.
BEHAVIORAL	Heart Rate Variability- Biofeedback	Heart Rate Variability- Biofeedback will be monitored with a Holter.
OTHER	Conventional Medical Therapy	Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication.

Timeline

• Start date: 2023-07-19
• Primary completion: 2024-07-30
• Completion: 2024-08-13
• First posted: 2023-10-31
• Last updated: 2024-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study