Premature Ventricular ComplexesTREAT-VTNCT07026695
Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias
A study testing transcutaenous vagal nerve stimulation in people with Premature Ventricular Complexes and Ventricular Tachycardia (VT), run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Complexes, Ventricular Tachycardia (VT), Ventricular Arrhythmias
- What is being tested?
- transcutaenous vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
St Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE
Nikhil Ahluwalia, MBBS, PhD, +44(0)20 3765 8682, nikhil.ahluwalia@nhs.net
Nikhil Ahluwalia, MBBS, PhD
About this study
Official title: Transcutaneous Electrical Vagus Nerve Stimulation for Suppression of Ventricular Arrhythmias
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.
- Being tested
- transcutaenous vagal nerve stimulation, Sham transcutaenous vagal nerve stimulation
- Keywords
- double-blinded, randomized, sham-controlled, crossover, prospective
- Medical subject headings
- Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaenous vagal nerve stimulationDevice
Low level Stimulation of the Auricular Branch of the Vagal Nerve at the tragus
Sham transcutaenous vagal nerve stimulationDevice
Sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Active Phase | Active comparator | Not described Receives: Device: transcutaenous vagal nerve stimulation |
| Sham Phase | Sham comparator | Not described Receives: Device: Sham transcutaenous vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 14 days
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ComplexesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomised, sham-controlled, crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier D Lambiase, BM BCh, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026695
- Sponsor's protocol ID
- 177627
- Acronym
- TREAT-VT
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Vagus Nerve Stimulation for Suppression of Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT07026695
- Acronym / sponsor ID
- TREAT-VT / 177627
- Keywords
- double-blinded, randomized, sham-controlled, crossover, prospective
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomised, sham-controlled, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Active Phase | Active comparator | Device: transcutaenous vagal nerve stimulation |
| Sham Phase | Sham comparator | Device: Sham transcutaenous vagal nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaenous vagal nerve stimulationLow level Stimulation of the Auricular Branch of the Vagal Nerve at the tragus | Device | Active Phase |
| Sham transcutaenous vagal nerve stimulationSham treatment | Device | Sham Phase |
Primary outcome
VT burden
Time frame: Six months
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
PVC Burden
Time frame: 14 days
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
3 secondary outcomes
50% reduction in VT burden
Time frame: Six months
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Score in the Active Phase versus Sham Control Phase (VT Cohort)
Time frame: Six months
Change in 36-Item Short Form Survey (SF-36) Score in the Active Phase versus Sham Control Phase (PVC Cohort)
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Premature Ventricular Complexes
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Recruiting
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier D Lambiase, BM BCh, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaenous vagal nerve stimulation in people with Premature Ventricular Complexes and Ventricular Tachycardia (VT), run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikhil Ahluwalia, MBBS, PhD (+44(0)2037658682, nikhil.ahluwalia@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT burden (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.