Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-19

Study Completion Date

2024-08-13

Brief Summary

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Prospective randomized control pilot study

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Detailed Description

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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

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Premature Ventricular Contraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-Level Tragus Stimulation

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

Group Type EXPERIMENTAL

Low-Level Tragus Stimulation

Intervention Type DEVICE

Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.

Heart Rate Variability- Biofeedback

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

Group Type EXPERIMENTAL

Heart Rate Variability- Biofeedback

Intervention Type BEHAVIORAL

Heart Rate Variability- Biofeedback will be monitored with a Holter.

Conventional Medical Therapy

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.

Group Type ACTIVE_COMPARATOR

Conventional Medical Therapy

Intervention Type OTHER

Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication.

Interventions

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Low-Level Tragus Stimulation

Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.

Intervention Type DEVICE

Heart Rate Variability- Biofeedback

Heart Rate Variability- Biofeedback will be monitored with a Holter.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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TENS Breathing Exercises / Inner Balance Usual care medication

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR