Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

NCT05341544 | Recruiting FDA Device

• 1 other identifier: 22-0076
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Premature Ventricular Contraction

Outcome Measures

Primary Outcomes (1)

• PVC Burden

  Daily PVC Count by event monitor

  28 days

Secondary Outcomes (3)

• Quality of life survey

  28 days

• Heart Rate Variability

  28 days

• PVC Morphology

  28 days

Study Arms (2)

Active

EXPERIMENTAL

Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.

Device: Parasym device

Sham

SHAM COMPARATOR

Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.

Device: Sham device

Interventions

Parasym device DEVICE

The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.

Active

Sham device DEVICE

Sham device

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwell Health: lead
• University of Oklahoma: collaborator

Study Sites (2)

Northwell Health

New York, New York, 10075, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40392172 DERIVED

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kristie Coleman, RN

CONTACT

212434650; kcoleman1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology, Lenox Hill Hospital

Model Details: Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: August 22, 2022
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (2)