Phase
Condition
Arrhythmia
Treatment
Sham device
Parasym device
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Study Description
Connect with a study center
Northwell Health
New York, New York 10075
United StatesActive - Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
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