Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Description

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

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Study Overview

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Study Details

Study overview

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)

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

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Condition
Premature Ventricular Contraction
Intervention / Treatment

-

Contacts and Locations

New York

Northwell Health, New York, New York, United States, 10075

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Study Record Dates

2025-08-22