Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Not Applicable

Recruiting

• Conditions: Premature Ventricular Contraction
• Interventions: Device: Sham device; Device: Parasym device

• Registration Number: NCT05341544
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Study Start: 2022-08-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-08-22
• Study Completion: 2024-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham	Sham device	Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.
Active	Parasym device	Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.

Primary Outcome Measures

Name	Time	Method
PVC Burden	28 days	Daily PVC Count by event monitor

Secondary Outcome Measures

Name	Time	Method
Heart Rate Variability	28 days	Daily HRV
Quality of life survey	28 days	SF 36 QOL Score
PVC Morphology	28 days	Fluctuation in PVC Morphology by event monitor

Trial Locations

Locations (2)

Northwell Health; 🇺🇸 New York, New York, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States