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Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias

NCT07026695 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-06-24

No results posted yet for this study

Summary

Ventricular arrhythmias are abnormal heart rhythms that arise from the bottom chambers of the heart. They can cause debilitating symptoms when they occur intermittently (these are called premature ventricular ectopics or PVCs) and can be life-threatening when they occur continuously (called ventricular tachycardia or VT). These are the most common causes of sudden cardiac death, especially in patients with pre-existing heart disease.

They can be a result of overactivation of the sympathetic nervous system, and in extreme circumstances, surgery to cut the nerve may be needed. A novel approach to target this nervous system using a transcutaneous electrical nerve stimulator (TENS) machine has successfully treated arrhythmias that come from the top chambers of the heart (atrial fibrillation). An ear clip is applied for an hour per day connected to a device (smaller than a phone) that can activate the parasympathetic nervous system (that counteracts the sympathetic nervous system). This is called Low-Level Tragus Stimulation (LLTS). Because it has been used for epilepsy for decades, we have evidence of a very high safety profile and tolerability. We plan to enrol 72 patients, 34 with many PVCs and 38 with VT, and randomise them to either first receive LLTS or first receive sham treatment (this will appear the same to the patient and researchers but without any meaningful vibrations being emitted in the sham group). Each patient will then swap over to the other treatment. We will compare whether the LLTS reduces the amount of ventricular arrhythmias during compared to the amount during the sham treatment period. We will use Holter monitors to measure the amount of PVCs after each period in the PVC group. VT patients have an implantable defibrillator that continuously monitors for VT episodes in this group. We will only enrol adults who can give informed consent, and study participation will not interfere with a patient's clinical treatment.

Conditions

  • Premature Ventricular Complexes
  • Ventricular Tachycardia (VT)
  • Ventricular Arrhythmias

Interventions

DEVICE

transcutaenous vagal nerve stimulation

Low level Stimulation of the Auricular Branch of the Vagal Nerve at the tragus

DEVICE

Sham transcutaenous vagal nerve stimulation

Sham treatment

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Pier D Lambiase, BM BCh, PhD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026695 on ClinicalTrials.gov