Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes ((NoVa-PVC))

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)

A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)

Study Overview

• Status: Completed
• Conditions: Premature Ventricular Contraction
• Intervention / Treatment: Device: Parasym device; Device: Sham device

Detailed Description

This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Northwell Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (>18 years old) but < 80 years of age
• Symptomatic PVCs or asymptomatic PVCs with a burden > 5%
• Intolerant to or unwilling to take beta blockers and nondihydropyridine calcium channel blockers or beta blockers and nondihydropyridine calcium channel blockers have proved ineffective

Exclusion Criteria:

• Ischemic cardiomyopathy with LVEF < 40%
• Severe heart failure (New York Heart Association Class III, or IV) or valve disease
• Sustained ventricular tachycardia
• Structural heart disease or myocardial scar
• Pregnancy or nursing
• Patients with known thyroid issues, on renal dialysis.
• Patients with prolonged first-degree block, high degree AV block (2nd or 3rd degree), bivascular block and documented sick sinus syndrome
• Hypotension due to autonomic dysfunction
• Patients with cardiac implantable electronic device (ICD or PPM) , hearing aid implants or any implanted metallic or electronic device
• Patients who have had prior cervical vagotomy
• Patients with skin on the tragus that is broken or cracked
• Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.	Device: Parasym device; The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.
Sham Comparator: Sham; Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.	Device: Sham device; Sham device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PVC Burden	Daily PVC Count by event monitor	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life survey	SF 36 QOL Score	28 days
Heart Rate Variability	Daily HRV	28 days
PVC Morphology	Fluctuation in PVC Morphology by event monitor	28 days

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: University of Oklahoma

Publications and helpful links

General Publications

• Zafeiropoulos S, Coleman K, Kogan J, Varrias D, Leavitt J, Bekiaridou A, Zanos T, Zanos S, Stavrakis S, Mountantonakis S. Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Premature Ventricular Contractions: A Crossover, Randomized Clinical Trial (NoVa-PVC). JACC Clin Electrophysiol. 2025 Aug;11(8):1699-1707. doi: 10.1016/j.jacep.2025.04.011. Epub 2025 Apr 24.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): April 6, 2026
• Study Completion (Actual): April 6, 2026

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Pathological Conditions, Signs and Symptoms; Ventricular Premature Complexes
• Other Study ID Numbers: 22-0076

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.: No