Vagus Nerve Stimulation for Neuromodulation (VNS-EPS Trial)

N/A

Recruiting

Led By Stavros E Mountantonakis, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre procedure/procedure

Awards & highlights

VNS-EPS Trial Summary

This trial is studying whether aVNS can improve heart function in people undergoing an electrophysiological study (EPS).

Who is the study for?

This trial is for individuals needing an electrophysiological study (EPS) to check their heart's electrical system or to investigate rapid heartbeats. It's not open to those who've had previous EPS with ablation, known conduction issues in the heart, are pregnant, have certain cardiovascular diseases, a history of vagotomy, skin conditions on the tragus, or active implanted medical devices.Check my eligibility

What is being tested?

The study tests auricular vagus nerve stimulation (aVNS), a non-invasive method that may affect the cardiac conduction system. Participants will undergo this stimulation during their scheduled EPS procedure at a single center in a pilot and prospective setup.See study design

What are the potential side effects?

Potential side effects of auricular vagus nerve stimulation can include discomfort at the site of stimulation, headache, dizziness or lightheadedness. However, since it's non-invasive and localized to the ear area, severe side effects are less likely compared to invasive procedures.

VNS-EPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a heart test to check for abnormal rhythms.

VNS-EPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre procedure/procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre procedure/procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre procedure/procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in A-H Interval

Change in AV Node Effective Refractory Period

Change in AV Node Wenckebach Cycle Length

+12 more

VNS-EPS Trial Design

1Treatment groups

Experimental Treatment

Group I: Auricular Vagal Nerve StimulationExperimental Treatment1 Intervention

Patients will undergo a standard EPS with 4 catheters. Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve, EPS will be repeated.

0 / 1Eligibility criteria met