Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes ((NoVa-PVC))

Northwell Health

Status: Enrolling

Conditions: Premature Ventricular Contraction

Treatments: Device: Sham device; Device: Parasym device

Study type: Interventional

Funder types: Other

Identifiers

NCT05341544

22-0076

Details and patient eligibility

About

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)

Full description

This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Active

Experimental group

Description:

Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.

Treatment:

Device: Parasym device

Sham

Sham Comparator group

Description:

Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.

Treatment:

Device: Sham device