Non-invasive stimulation to reduce frequent heartbeats
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
This study is testing if a gentle stimulation technique can help people with frequent heartbeats feel better by comparing it to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05341544 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of low-level tragus stimulation (LLTS) on patients experiencing frequent premature ventricular complexes (PVCs). It is a two-center, prospective, cross-over, sham-controlled, double-blinded trial where participants will undergo two treatment periods: one with LLTS and one with sham stimulation, each lasting 10 days. Patients will be monitored continuously for 28 days using a cardiac event monitor to assess the impact of the interventions on their PVC burden.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic PVCs or asymptomatic PVCs with a burden greater than 5%, who cannot tolerate or have not responded to traditional medications.
Not a fit: Patients with severe heart conditions, structural heart disease, or those with implanted electronic devices are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients suffering from frequent PVCs.
How similar studies have performed: While this approach is innovative, similar non-invasive stimulation techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York and 1 other locations
- Northwell Health — New York, New York, United States (Recruiting)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Kristie Coleman, RN
- Email: kcoleman1@northwell.edu
- Phone: 212434650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.