Clinical trial NCT07026695: Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias
Official title: Transcutaneous Electrical Vagus Nerve Stimulation for Suppression of Ventricular Arrhythmias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Ventricular Complexes
Ventricular Tachycardia (VT)
Ventricular Arrhythmias
Keywords: double-blinded
randomized
sham-controlled
crossover
prospective
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded, randomised, sham-controlled, crossover trial
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: VT burden
timeFrame: Six months
measure: PVC Burden
timeFrame: 14 days
Secondary outcomes:
measure: 50% reduction in VT burden
timeFrame: Six months
measure: Quality of Life score
timeFrame: Six months
measure: Quality of Life score
timeFrame: 28 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital, Barts Health NHS Trust
Study officials:
affiliation: University College, London
name: Pier D Lambiase, BM BCh, PhD
role: PRINCIPAL_INVESTIGATOR
References: