Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT05377216
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2022-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-05-02', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular Effective Refractory Period', 'timeFrame': '30 minutes following stellate ganglion block', 'description': 'Change in Ventricular Effective Refractory Period at 600ms drive train (measured in milliseconds)'}], 'secondaryOutcomes': [{'measure': 'Ventricular Arrhythmia Inducibility', 'timeFrame': '30 minutes following stellate ganglion block', 'description': 'Induction of monomorphic ventricular arrhythmia (binary outcome) during ventricular programmed stimulation'}, {'measure': 'Neuropeptide Y', 'timeFrame': '30 minutes following stellate ganglion block', 'description': 'Change in level of neuropeptide Y from baseline (measured in pg/mL)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned catheter based VT ablation\n* Age at least 18 years\n\nExclusion Criteria:\n\n* Pregnancy\n* Contraindication to SGB or VT ablation\n* Hypersensitivity of local anesthetic of amide type\n* Hemodynamic instability during the procedure prior to the study protocol'}, 'identificationModule': {'nctId': 'NCT05377216', 'briefTitle': 'Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation', 'orgStudyIdInfo': {'id': '851066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stellate ganglion block', 'description': 'All subjects will undergo stellate ganglion block during their VT ablation procedure', 'interventionNames': ['Drug: Stellate Ganglion Block']}], 'interventions': [{'name': 'Stellate Ganglion Block', 'type': 'DRUG', 'description': 'Left sided percutaneous stellate ganglion block', 'armGroupLabels': ['Stellate ganglion block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timothy Markman, MD', 'role': 'CONTACT'}], 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Timothy Markman, MD', 'role': 'CONTACT', 'email': 'timothy.markman@pennmedicine.upenn.edu', 'phone': '267-593-0103'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}