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Recruiting NCT05341544

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Trial Parameters

Condition Premature Ventricular Contraction
Sponsor Northwell Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2022-08-22
Completion 2025-12-22
Interventions
Parasym deviceSham device

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)

Eligibility Criteria

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 * Pa

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