Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT04359004
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-21', 'releaseDate': '2024-06-26'}, {'resetDate': '2024-09-10', 'releaseDate': '2024-08-19'}], 'estimatedResultsFirstSubmitDate': '2024-06-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in ventricular action potential duration during stimulation compared to baseline in msec', 'timeFrame': 'Up to 30 minutes or completion of the vagus nerve stimulation'}], 'secondaryOutcomes': [{'measure': 'The change in blood pressure during stimulation compared to baseline in mmHg.', 'timeFrame': 'Up to 30 minutes or completion of the vagus nerve stimulation'}, {'measure': 'The change in heart rate during stimulation compared to baseline in beats per minute', 'timeFrame': 'Up to 30 minutes or completion of the vagus nerve stimulation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Vagus Nerve Stimulation (VNS)', 'Activation Recovery Interval (ARI)'], 'conditions': ['Arrhythmia', 'Ventricular Tachycardia (VT)']}, 'referencesModule': {'references': [{'pmid': '28814663', 'type': 'BACKGROUND', 'citation': 'Vaseghi M, Salavatian S, Rajendran PS, Yagishita D, Woodward WR, Hamon D, Yamakawa K, Irie T, Habecker BA, Shivkumar K. Parasympathetic dysfunction and antiarrhythmic effect of vagal nerve stimulation following myocardial infarction. JCI Insight. 2017 Aug 17;2(16):e86715. doi: 10.1172/jci.insight.86715. eCollection 2017 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.', 'detailedDescription': "This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.\n* Age \\> 18 years old\n* Underlying sinus rhythm with heart rate \\> 50 bpm.\n* Provision of signed/dated informed consent and stated willingness to comply with all study procedures\n\nExclusion Criteria:\n\n* Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\\>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).\n* Status post orthotopic heart transplantation\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).\n* Unable or unwilling to comply with protocol requirements.\n* Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.\n* Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.\n* New York Heart Association Class IV heart failure or use of current vasopressor medications\n* Incessant VT\n* Persistent atrial fibrillation\n* Frequent premature atrial or ventricular contractions\n* Inability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT04359004', 'briefTitle': 'A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation', 'orgStudyIdInfo': {'id': '19-001929'}, 'secondaryIdInfos': [{'id': 'OT2OD028201', 'link': 'https://reporter.nih.gov/quickSearch/OT2OD028201', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Vagus Nerve Stimulation (VNS)', 'type': 'OTHER', 'description': "Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded."}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Kalyanam Shivkumar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, UCLA Cardiac Arrhythmia Center & EP Programs', 'investigatorFullName': 'Kalyanam Shivkumar, MD, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-26', 'type': 'RELEASE'}, {'date': '2024-07-21', 'type': 'RESET'}, {'date': '2024-08-19', 'type': 'RELEASE'}, {'date': '2024-09-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kalyanam Shivkumar, MD, PhD, Director, UCLA Cardiac Arrhythmia Center & EP Programs, University of California, Los Angeles'}}}}