Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Last updated: September 24, 2024
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Treatment

Sham device

Parasym device

Clinical Study ID

NCT05341544
22-0076
  • Ages 18-80
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 calciumchannel blockers or beta blockers and nondihydropyridine calcium channel blockershave proved ineffective

Exclusion

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 3rddegree), bivascular block and documented sick sinus syndrome

  • Hypotension due to autonomic dysfunction

  • Patients with cardiac implantable electronic device (ICD or PPM) , hearing aidimplants 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 atheroscleroticcardiovascular disease, including congestive heart failure (CHF), known severecoronary artery disease or recent myocardial infarction (within 5 years) andpatients diagnosed with narrowing of the arteries (carotid atherosclerosis)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Sham device
Phase:
Study Start date:
August 22, 2022
Estimated Completion Date:
August 22, 2025

Study 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.

Connect with a study center

  • Northwell Health

    New York, New York 10075
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

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