Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

NCT06110364 | Withdrawn Phase 3 FDA Device

• 1 other identifier: 1724039
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized control pilot study

Conditions

Premature Ventricular Contraction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.

  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 Outcomes (1)

• 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)

Study Arms (3)

Low-Level Tragus Stimulation

EXPERIMENTAL

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

Device: Low-Level Tragus Stimulation

Heart Rate Variability- Biofeedback

EXPERIMENTAL

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

Conventional Medical Therapy

ACTIVE COMPARATOR

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

Interventions

Low-Level Tragus Stimulation DEVICE

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

Also known as: TENS

Low-Level Tragus Stimulation

Heart Rate Variability- Biofeedback BEHAVIORAL

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

Also known as: Breathing Exercises / Inner Balance

Heart Rate Variability- Biofeedback

Conventional Medical Therapy 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.

Also known as: Usual care medication

Conventional Medical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal Left Ventricular systolic function
• Frequent PVCs

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

Richmond VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Links

• Premature ventricular contractions activate vagal afferents and alter autonomic tone: implications for premature ventricular contraction-induced cardiomyopathy
• Relationship between burden of premature ventricular complexes and left ventricular function
• Clinical and translational insights on premature ventricular contractions and PVC-induced cardiomyopathy
• Evaluation and management of premature ventricular complexes
• Stellate ganglion blockade and bilateral cardiac sympathetic denervation in patients with life-threatening ventricular arrhythmias
• Cardiac Sympathetic Denervation for Refractory Ventricular Arrhythmias
• TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial
• Heart rate variability biofeedback based on slow-paced breathing with immersive virtual reality nature scenery.
• Non-invasive low-level tragus stimulation in cardiovascular diseases
• Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Transcutaneous Electric Nerve Stimulation; Breathing Exercises

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques

Study Officials

• Jose Huizar, M.D.

  Hunter Holmes McGuire Veterans Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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)

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: July 19, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 13, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

US (1)