Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias

NCT07026695 | Not Yet Recruiting

• 1 other identifier: 177627
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

double-blinded; randomized; sham-controlled; crossover; prospective

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 days

Secondary Outcomes (3)

• 50% reduction in VT burden

  Six months

• Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Score in the Active Phase versus Sham Control Phase (VT Cohort)

  Six months

• Change in 36-Item Short Form Survey (SF-36) Score in the Active Phase versus Sham Control Phase (PVC Cohort)

  28 days

Study Arms (2)

Active Phase

ACTIVE COMPARATOR

Device: transcutaenous vagal nerve stimulation

Sham Phase

SHAM COMPARATOR

Device: Sham transcutaenous vagal nerve stimulation

Interventions

transcutaenous vagal nerve stimulation DEVICE

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

Active Phase

Sham transcutaenous vagal nerve stimulation DEVICE

Sham treatment

Sham Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

St Bartholomew's Hospital, Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Study Officials

• Pier D Lambiase, BM BCh, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikhil Ahluwalia, MBBS, PhD

CONTACT

+44(0)2037658682; nikhil.ahluwalia@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, randomised, sham-controlled, crossover trial

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)