RecruitingNot ApplicableNCT05341544
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
Sponsor
Northwell Health
Enrollment
60 participants
Start Date
Aug 22, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria3
- 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 Criteria12
- 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)
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Interventions
DEVICEParasym device
The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.
DEVICESham device
Sham device
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05341544