An interventional study of transcutaenous vagal nerve stimulation and Sham transcutaenous vagal nerve stimulation in Premature Ventricular Complexes, Ventricular Tachycardia (VT) and Ventricular Arrhythmias, sponsored by University College, London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's planned enrollment of 72 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
PVC Cohort
Inclusion Criteria:
Exclusion Criteria:
VT cohort
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: transcutaenous vagal nerve stimulation
Device: Sham transcutaenous vagal nerve stimulation
Low level Stimulation of the Auricular Branch of the Vagal Nerve at the tragus
Sham treatment
VT burden
Change in per-subject VT burden as adjudicated by continuous ICD monitoring during the active period versus the sham period (VT burden = the number of ATP events, ICD shocks and sustained (\>30 seconds) VT episodes) in the VT cohort
Time frame: Six months
PVC Burden
Change in per-subject PVC burden compared to baseline during the active period versus sham period on 14-day Holter monitoring at the end of the period in the PVC cohort
Time frame: 14 days
50% reduction in VT burden
The proportion of patients with a 50% reduction in VT burden following LLTS as adjudicated by continuous ICD monitoring (VT burden = number of ATP and ICD shocks and sustained (\>30 seconds) VT) in the VT cohort
Time frame: Six months
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Score in the Active Phase versus Sham Control Phase (VT Cohort)
The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a validated disease-specific instrument for patients with heart failure. Scores range from 0 to 100, where higher scores indicate better health status, including better symptom control, functional status, and quality of life.
Time frame: Six months
Change in 36-Item Short Form Survey (SF-36) Score in the Active Phase versus Sham Control Phase (PVC Cohort)
The 36-Item Short Form Survey (SF-36) assesses general health-related quality of life. Each domain score and the overall score range from 0 to 100, with higher scores indicating better perceived health and functioning.
Time frame: 28 days
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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