Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT07026695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blinded, randomised, sham-controlled, crossover trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VT burden', 'timeFrame': 'Six months', 'description': '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'}, {'measure': 'PVC Burden', 'timeFrame': '14 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': '50% reduction in VT burden', 'timeFrame': 'Six months', 'description': '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'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Score in the Active Phase versus Sham Control Phase (VT Cohort)', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Change in 36-Item Short Form Survey (SF-36) Score in the Active Phase versus Sham Control Phase (PVC Cohort)', 'timeFrame': '28 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['double-blinded', 'randomized', 'sham-controlled', 'crossover', 'prospective'], 'conditions': ['Premature Ventricular Complexes', 'Ventricular Tachycardia (VT)', 'Ventricular Arrhythmias']}, 'descriptionModule': {'briefSummary': "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.\n\nThey 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PVC Cohort\n\nInclusion Criteria:\n\n* Age \\> 18 years old.\n* Participants must understand and be willing to sign a written informed consent document.\n* PVC burden of \\>10% in a 24-hour period on Holter monitoring.\n\nExclusion Criteria:\n\n* Coronary artery disease\n* 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.\n* A known diagnosis of Epilepsy.\n* Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.\n* Participants using a TENS device for any indication\n\nVT cohort\n\nInclusion Criteria:\n\n* Participants with structural heart disease and a transvenous implantable cardioverter defibrillator (ICD) in situ\n* 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\n\nExclusion Criteria:\n\n* Heart failure syndrome with inotrope dependency or requiring mechanical assistance.\n* Reversible cause of arrhythmia (e.g. culprit electrolyte abnormality or toxin)\n* NYHA (New York Heart Association) stage IV heart failure\n* Myocardial infarction or cardiac surgery in the last six months\n* Life expectancy \\<12 months\n* Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.\n* Participants using a TENS device for any indication'}, 'identificationModule': {'nctId': 'NCT07026695', 'acronym': 'TREAT-VT', 'briefTitle': 'Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Transcutaneous Electrical Vagus Nerve Stimulation for Suppression of Ventricular Arrhythmias', 'orgStudyIdInfo': {'id': '177627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Phase', 'interventionNames': ['Device: transcutaenous vagal nerve stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Phase', 'interventionNames': ['Device: Sham transcutaenous vagal nerve stimulation']}], 'interventions': [{'name': 'transcutaenous vagal nerve stimulation', 'type': 'DEVICE', 'description': 'Low level Stimulation of the Auricular Branch of the Vagal Nerve at the tragus', 'armGroupLabels': ['Active Phase']}, {'name': 'Sham transcutaenous vagal nerve stimulation', 'type': 'DEVICE', 'description': 'Sham treatment', 'armGroupLabels': ['Sham Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Nikhil Ahluwalia, MBBS, PhD', 'role': 'CONTACT', 'email': 'nikhil.ahluwalia@nhs.net', 'phone': '+44(0)20 3765 8682'}, {'name': 'Nikhil Ahluwalia, MBBS, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pier D Lambiase, BM BCh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St Bartholomew's Hospital, Barts Health NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Nikhil Ahluwalia, MBBS, PhD', 'role': 'CONTACT', 'email': 'nikhil.ahluwalia@nhs.net', 'phone': '+44(0)2037658682'}], 'overallOfficials': [{'name': 'Pier D Lambiase, BM BCh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}