Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
Completed · Not applicable · Has a placebo group
Conditions studied: Premature Ventricular Contraction
In brief
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)
Key facts
- Study ID
- NCT05341544
- Run by
- Northwell Health
- People needed
- 60
- Starts
- 2022-08-22
- Expected to finish
- 2026-04-06
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Northwell Health — New York, New York, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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