Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Phase 3

Withdrawn

• Conditions: Premature Ventricular Contraction
• Interventions: Behavioral: Heart Rate Variability- Biofeedback; Other: Conventional Medical Therapy; Device: Low-Level Tragus Stimulation

• Registration Number: NCT06110364
• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

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.

Study Timeline

• Study Start: 2023-07-19
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-31
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Heart Rate Variability- Biofeedback	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.
Conventional Medical Therapy	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.
Low-Level Tragus Stimulation	Low-Level Tragus Stimulation	The Low-Level Tragus Stimulation will be done with TENS.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Richmond VA Medical Center; 🇺🇸 Richmond, Virginia, United States