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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
View on ClinicalTrials.gov →
NCT05341544
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 siteOklahoma
1 siteUniversity of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Natalia Serrano405-271-9696
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Actively Recruiting
PhaseN/A
SponsorNorthwell Health
Started2022-08-22
Est. completion2025-12-22
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05341544