Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06110364

Enrollment

Registered

2023-10-31

Start date

2023-07-19

Completion date

2024-08-13

Last updated

2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ventricular Contraction

Keywords

NIVNS Non-invasive vagal nerve stimulation, LLTS- Low-level tragus stimulation, HRV-BF - Heart rate variability biofeedback

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.

Interventions

DEVICELow-Level Tragus Stimulation

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

BEHAVIORALHeart Rate Variability- Biofeedback

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

OTHERConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.	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

Measure	Time frame	Description
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)	It is speculated that Heart Rate Variability-Biofeedback is as effective as Lower Level Tragus Stimulation to achieve successful Premature Ventricular Contraction suppression.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026