Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Study Overview
=================
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.

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

Conditions
-----------------
Premature Ventricular Contraction

Intervention / Treatment
-----------------
* Device: Parasym device
* Device: Sham device


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Patients will receive 1 hour of active low level tragus stimulation daily for 10 days. | Device: Parasym device<br>* The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.<br>|
| Sham Comparator: Sham<br>Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days. | Device: Sham device<br>* Sham device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVC Burden | Daily PVC Count by event monitor | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life survey | SF 36 QOL Score | 28 days | 
| Heart Rate Variability | Daily HRV | 28 days | 
| PVC Morphology | Fluctuation in PVC Morphology by event monitor | 28 days |