Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
Northwell Health
RECRUITING
New York
Oklahoma
University of Oklahoma Health Sciences Center
NOT_YET_RECRUITING
Oklahoma City
Contact Information
Primary
Kristie Coleman, RN
kcoleman1@northwell.edu
212434650
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2025-12-22
Participants
Target number of participants: 60
Treatments
Experimental: Active
Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.
Sham_comparator: Sham
Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.
Related Therapeutic Areas
Sponsors
Collaborators: University of Oklahoma
Leads: Northwell Health