Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias

Launched by UNIVERSITY COLLEGE, LONDON · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, non-invasive treatment for abnormal heart rhythms that come from the lower chambers of the heart, called ventricular arrhythmias. These include premature ventricular complexes (PVCs), which happen occasionally and can cause symptoms, and ventricular tachycardia (VT), a more serious and continuous fast heartbeat that can be life-threatening. The trial is testing a device that uses gentle electrical stimulation on a part of the ear (called the tragus) to help calm the nervous system and reduce these abnormal heartbeats. This method, known as Low-Level Tragus Stimulation (LLTS), is easy to use, safe, and has been used for other conditions like epilepsy for many years.

Adults with frequent PVCs or with VT who have a special heart device implanted (an ICD) may be eligible to join, as long as they meet certain health criteria. Participants will wear an ear clip connected to a small device for about one hour each day, which either delivers the real stimulation or a fake (sham) treatment that feels the same but doesn’t actually stimulate the nerve. Everyone will try both treatments at different times, allowing researchers to compare their effects. The study will monitor heart rhythms using portable heart monitors or the implanted devices to see if LLTS helps reduce the abnormal heartbeats. Joining the study won’t interfere with a patient’s regular medical care, and only adults who can give informed consent will be enrolled.

Gender

ALL

Eligibility criteria

• • PVC Cohort
• Inclusion Criteria:
• • Age \> 18 years old.
• • Participants must understand and be willing to sign a written informed consent document.
• • PVC burden of \>10% in a 24-hour period on Holter monitoring.
• Exclusion Criteria:
• • Coronary artery disease
• • Known cardiac disease (heart failure or cardiomyopathy) in the documented absence of PVCs. Individuals with suspected PVC-induced cardiomyopathy heart failure, defined as cardiomyopathy or heart failure only diagnosed in the setting of a \>10% PVC burden, will be allowed to participate.
• • A known diagnosis of Epilepsy.
• • Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.
• • Participants using a TENS device for any indication
• • VT cohort
• Inclusion Criteria:
• • Participants with structural heart disease and a transvenous implantable cardioverter defibrillator (ICD) in situ
• • At least three clinically significant VT events (VT events defined as either \>30 seconds of sustained VT, appropriate ICD ATP therapies or appropriate ICD shocks) in the six months before enrolment
• Exclusion Criteria:
• • Heart failure syndrome with inotrope dependency or requiring mechanical assistance.
• • Reversible cause of arrhythmia (e.g. culprit electrolyte abnormality or toxin)
• • NYHA (New York Heart Association) stage IV heart failure
• • Myocardial infarction or cardiac surgery in the last six months
• • Life expectancy \<12 months
• • Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.
• • Participants using a TENS device for any indication