Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Premature Ventricular Contraction Clinical Trial

Official title:

Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06110364
• Other study ID #: 1724039
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: Pouria Shoureshi, M.D.
• Phone: 804-675-5151
• Email: Pouria.Shoureshi[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective randomized control pilot study

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Intervention

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

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

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.

Locations

Country	Name	City	State
United States	Richmond VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Baman TS, Lange DC, Ilg KJ, Gupta SK, Liu TY, Alguire C, Armstrong W, Good E, Chugh A, Jongnarangsin K, Pelosi F Jr, Crawford T, Ebinger M, Oral H, Morady F, Bogun F. Relationship between burden of premature ventricular complexes and left ventricular func — View Citation

Blum J, Rockstroh C, Goritz AS. Heart Rate Variability Biofeedback Based on Slow-Paced Breathing With Immersive Virtual Reality Nature Scenery. Front Psychol. 2019 Sep 20;10:2172. doi: 10.3389/fpsyg.2019.02172. eCollection 2019. — View Citation

Cantillon DJ. Evaluation and management of premature ventricular complexes. Cleve Clin J Med. 2013 Jun;80(6):377-87. doi: 10.3949/ccjm.80a.12168. — View Citation

Cardona-Guarache R, Padala SK, Velazco-Davila L, Cassano A, Abbate A, Ellenbogen KA, Koneru JN. Stellate ganglion blockade and bilateral cardiac sympathetic denervation in patients with life-threatening ventricular arrhythmias. J Cardiovasc Electrophysiol — View Citation

Huizar JF, Tan AY, Kaszala K, Ellenbogen KA. Clinical and translational insights on premature ventricular contractions and PVC-induced cardiomyopathy. Prog Cardiovasc Dis. 2021 May-Jun;66:17-27. doi: 10.1016/j.pcad.2021.04.001. Epub 2021 Apr 20. — View Citation

Jiang Y, Po SS, Amil F, Dasari TW. Non-invasive Low-level Tragus Stimulation in Cardiovascular Diseases. Arrhythm Electrophysiol Rev. 2020 Jun 3;9(1):40-46. doi: 10.15420/aer.2020.01. — View Citation

Salavatian S, Yamaguchi N, Hoang J, Lin N, Patel S, Ardell JL, Armour JA, Vaseghi M. Premature ventricular contractions activate vagal afferents and alter autonomic tone: implications for premature ventricular contraction-induced cardiomyopathy. Am J Phys — View Citation

Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillat — View Citation

Vaseghi M, Barwad P, Malavassi Corrales FJ, Tandri H, Mathuria N, Shah R, Sorg JM, Gima J, Mandal K, Saenz Morales LC, Lokhandwala Y, Shivkumar K. Cardiac Sympathetic Denervation for Refractory Ventricular Arrhythmias. J Am Coll Cardiol. 2017 Jun 27;69(25 — View Citation

Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020 Apr 28;14:284. doi: 10.3389/fnins.2020.00284. eCollection 2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.	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)

External Links

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