Premature Ventricular Contraction
Conditions
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.
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
Sponsors
Northwell Health
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PVC Burden | 28 days | Daily PVC Count by event monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life survey | 28 days | SF 36 QOL Score |
| Heart Rate Variability | 28 days | Daily HRV |
| PVC Morphology | 28 days | Fluctuation in PVC Morphology by event monitor |
Countries
United States
Outcome results
None listed