Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

October 23, 2024 updated by: Jose Huizar, Hunter Holmes Mcguire Veteran Affairs Medical Center
Prospective randomized control pilot study

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Richmond VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-Level Tragus Stimulation
The Low-Level Tragus Stimulation will be done with TENS.
Device: Low-Level Tragus Stimulation
Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.
Other Names:
  • TENS
Experimental: 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.
Behavioral: Heart Rate Variability- Biofeedback
Heart Rate Variability- Biofeedback will be monitored with a Holter.
Other Names:
  • Breathing Exercises / Inner Balance
Active Comparator: 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.
Other: 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.
Other Names:
  • Usual care medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.
Time Frame: 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.
perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Collaborators

Virginia Commonwealth University

Investigators

  • Principal Investigator: Jose Huizar, M.D., Hunter Holmes McGuire Veterans Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

August 13, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1724039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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