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Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

RECRUITINGN/ASponsored by Northwell Health
Actively Recruiting
PhaseN/A
SponsorNorthwell Health
Started2022-08-22
Est. completion2025-12-22
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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)

Conditions2

Heart DiseasePremature Ventricular Contraction

Locations2 sites

New York

1 site
Northwell Health
New York, New York, 10075
Kristie Coleman212-434-6500kcoleman1@northwell.edu

Oklahoma

1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Natalia Serrano405-271-9696

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