Non-invasive vagus nerve stimulation for heart function evaluation
Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)
NA · Northwell Health · NCT05350150
This study is testing whether a new non-invasive treatment that stimulates a nerve in the ear can improve heart function in healthy people during heart tests.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05350150 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effects of auricular vagus nerve stimulation (aVNS) on the cardiac conduction system in healthy individuals undergoing an electrophysiological study. Participants will receive standard electrophysiological assessments using multiple catheters, followed by non-invasive stimulation of the auricular branch of the vagus nerve using a specialized device. The goal is to understand how aVNS may influence heart function and conduction pathways.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals scheduled for an electrophysiological study to evaluate cardiac conduction or supraventricular tachycardia.
Not a fit: Patients with prior cardiac conditions, previous ablations, or those with active medical devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive method to improve cardiac function and treatment for patients with conduction system disorders.
How similar studies have performed: While the specific application of aVNS in this context is novel, similar neuromodulation techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia. Exclusion Criteria: * Previous EPS with ablation * Previous failed ablation * Known conduction system disease, right or left bundle branch block on EKG * Pregnant women * History of postural orthostatic tachycardia syndrome * 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) * Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.
Where this trial is running
New York, New York
- Kristie Coleman — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Stavros E Mountantonakis, MD — Northwell Health
- Study coordinator: Kristie Coleman, RN
- Email: kcoleman1@northwell.edu
- Phone: 2124346500
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.
Conditions: Neuromodulation