Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias

NCT ID: NCT07026695

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Phase

Group Type: ACTIVE_COMPARATOR

transcutaenous vagal nerve stimulation

Intervention Type: DEVICE

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

Sham Phase

Group Type: SHAM_COMPARATOR

Sham transcutaenous vagal nerve stimulation

Intervention Type: DEVICE

Sham treatment

Interventions

transcutaenous vagal nerve stimulation

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

Intervention Type: DEVICE

Sham transcutaenous vagal nerve stimulation

Sham treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pier D Lambiase, BM BCh, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

St Bartholomew's Hospital, Barts Health NHS Trust

London, , United Kingdom

Countries

United Kingdom

Central Contacts

Nikhil Ahluwalia, MBBS, PhD

Role: CONTACT

nikhil.ahluwalia@nhs.net

+44(0)2037658682

Facility Contacts

Nikhil Ahluwalia, MBBS, PhD

Role: primary

nikhil.ahluwalia@nhs.net

+44(0)20 3765 8682

Other Identifiers

177627

Identifier Type: -

Identifier Source: org_study_id