Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Premature Ventricular Contraction
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief 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.
Investigators
Jose Huizar
Associate Chief of Staff for Research and Development at VAMC, Professor of Medicine at VCU, Director, Arrhythmia and Device Clinic at VAMC and Affiliate Professor of Physiology and Biophysics VCU
Hunter Holmes Mcguire Veteran Affairs Medical Center
Eligibility Criteria
Inclusion Criteria
- •Normal Left Ventricular systolic function
- •Frequent PVCs
Exclusion Criteria
- •Current use of any (I and/or III) antiarrhythmic medication
- •Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers
- •Complete Atrioventricular block and pacemaker dependent
- •Ongoing uncontrolled hypertension with systolic Blood Pressure\> 180
- •Family history of dilated Cardiomyopathy in a first degree relative
- •Alcohol use disorder or illicit drug use
- •Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response
- •Moderate to severe valve disorders
- •Patient with shortwave/microwave therapy equipment
Outcomes
Primary Outcomes
Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
Time Frame: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)
Compare the effects of Premature Ventricular Contractions suppression between standard medical therapy and non-invasive vagal nerve stimulation.
Secondary Outcomes
- Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.(perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm))