Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Premature Ventricular Contraction Clinical Trial

— (NoVa-PVC)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341544
• Other study ID #: 22-0076
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: September 22, 2024

Study information

• Verified date: August 2023
• Source: Northwell Health
• Contact: Kristie Coleman, RN
• Phone: 212434650
• Email: kcoleman1[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 22, 2024
• Est. primary completion date: August 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Intervention

Device:
• Parasym device
The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.
• Sham device
Sham device

Locations

Country	Name	City	State
United States	Northwell Health	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVC Burden	Daily PVC Count by event monitor	28 days
Secondary	Quality of life survey	SF 36 QOL Score	28 days
Secondary	Heart Rate Variability	Daily HRV	28 days
Secondary	PVC Morphology	Fluctuation in PVC Morphology by event monitor	28 days