Clinical trial NCT05341544: Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
Official title: Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Ventricular Contraction
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2022-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: PVC Burden
timeFrame: 28 days
Secondary outcomes:
measure: Quality of life survey
timeFrame: 28 days
measure: Heart Rate Variability
timeFrame: 28 days
measure: PVC Morphology
timeFrame: 28 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Northwell Health
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
References: