Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status and phase: Withdrawn; Phase 3

Conditions: Premature Ventricular Contraction

Treatments: Device: Low-Level Tragus Stimulation; Behavioral: Heart Rate Variability- Biofeedback; Other: Conventional Medical Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06110364

1724039

Details and patient eligibility

About

Prospective randomized control pilot study

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Low-Level Tragus Stimulation

Experimental group

Description:

The Low-Level Tragus Stimulation will be done with TENS.

Treatment:

Device: Low-Level Tragus Stimulation

Heart Rate Variability- Biofeedback

Experimental group

Description:

Heart Rate Variability-Biofeedback will be done with a phone application. Practice sessions are at least 10-15 minutes twice a daily.

Treatment:

Behavioral: Heart Rate Variability- Biofeedback

Conventional Medical Therapy

Active Comparator group

Description:

Subjects without beta blockers will be initiated on a usual/standard care medication of beta blockers to determine the efficacy of this standard medication therapy for Premature Ventricular Contraction suppression.

Treatment:

Other: Conventional Medical Therapy