Status:
RECRUITING
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
University of Oklahoma
Conditions:
Premature Ventricular Contraction
Eligibility:
All Genders
18-80 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05341544
Start Date
August 22 2022
End Date
December 22 2025
Last Update
September 15 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwell Health
New York, New York, United States, 10075
2
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104