Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04043312
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2019-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Magnetic Stimulation to Treat VT Storm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.markman@uphs.upenn.edu', 'phone': '267-593-0103', 'title': 'Dr. Timothy Markman', 'organization': 'Hospital of the University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For 72 hours after enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-hours following completion of the protocol', 'description': 'Incidence of ventricular tachycardia on inpatient telemetry monitoring', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48-hours following completion of the protocol', 'description': 'Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Changes in ICD or Pacemaker Lead Impedances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Number of patients with changes in lead impedance (unit: Ohms) on device interrogation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with CIED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Changes in ICD or Pacemaker Lead Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Number of patients with changes in lead thresholds (unit: mV) on device interrogation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with CIED'}, {'type': 'SECONDARY', 'title': 'Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Number of patient with changes in lead sensitivity (unit: mA) on device interrogation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable.', 'unitOfMeasure': 'Pain score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Nonsedated patients'}, {'type': 'SECONDARY', 'title': 'Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours following completion of the protocol', 'description': 'Incidence of antiarrhythmic drug use post stimulation per inpatient medical record', 'unitOfMeasure': 'Agents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Changes in ECG Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following completion of the stimulation', 'description': 'Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'OG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following the completion of the stimulation', 'description': 'Number of patients with clinical significant change in heart rate or blood pressure during the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'FG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Patients will receive one hour of sham stimulation.\n\nMagstim SuperRapid: Sham transcutaneous magnetic stimulation.'}, {'id': 'BG001', 'title': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.\n\nMagstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.7', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '66.9', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Episodes of VT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.8', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '11.0', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '12.7', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Antiarrhythmic Drugs Failed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Drugs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mechanical hemodynamic support', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-04', 'size': 152093, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-04T13:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2019-07-25', 'resultsFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-01', 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring', 'timeFrame': '24-hours following completion of the protocol', 'description': 'Incidence of ventricular tachycardia on inpatient telemetry monitoring'}], 'secondaryOutcomes': [{'measure': 'Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry', 'timeFrame': '48-hours following completion of the protocol', 'description': 'Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry'}, {'measure': 'Number of Patients With Changes in ICD or Pacemaker Lead Impedances', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Number of patients with changes in lead impedance (unit: Ohms) on device interrogation'}, {'measure': 'Number of Patients With Changes in ICD or Pacemaker Lead Thresholds', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Number of patients with changes in lead thresholds (unit: mV) on device interrogation'}, {'measure': 'Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Number of patient with changes in lead sensitivity (unit: mA) on device interrogation'}, {'measure': 'Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)', 'timeFrame': 'Immediately following completion of the protocol', 'description': 'Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable.'}, {'measure': 'Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record', 'timeFrame': '24 hours following completion of the protocol', 'description': 'Incidence of antiarrhythmic drug use post stimulation per inpatient medical record'}, {'measure': 'Number of Patients With Changes in ECG Parameters', 'timeFrame': 'Immediately following completion of the stimulation', 'description': 'Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation.'}, {'measure': 'Number of Patients With Changes in Vital Signs', 'timeFrame': 'Immediately following the completion of the stimulation', 'description': 'Number of patients with clinical significant change in heart rate or blood pressure during the procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventricular Tachycardia']}, 'referencesModule': {'references': [{'pmid': '35171197', 'type': 'DERIVED', 'citation': 'Markman TM, Pothineni NVK, Zghaib T, Smietana J, McBride D, Amankwah NA, Linn KA, Kumareswaran R, Hyman M, Arkles J, Santangeli P, Schaller RD, Supple GE, Frankel DS, Deo R, Lin D, Riley MP, Epstein AE, Callans DJ, Marchlinski FE, Hamilton R, Nazarian S. Effect of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm: A Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):445-449. doi: 10.1001/jamacardio.2021.6000.'}]}, 'descriptionModule': {'briefSummary': 'Ventricular Tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource utilization. Several therapies are utilized including sympathetic blockade (through deep sedation and beta blockers), antiarrhythmic drugs, implantable cardioverter defibrillator (ICD) reprograming where applicable, and catheter ablation. Despite standard intervention, mortality rates remain high and additional therapeutic options are actively being investigated.\n\nThe overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. This is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 3 episodes of VT in 24 hours\n\nExclusion Criteria:\n\n* Pregnancy\n* Implanted ventricular assist device\n* Metal implanted in head or neck (except the mouth)\n* Implanted medication pumps\n* Cochlear implant\n* Implanted brain stimulator\n* Ocular implant\n* History of active malignancy in region of stimulation (neck)'}, 'identificationModule': {'nctId': 'NCT04043312', 'acronym': 'STAR-VT', 'briefTitle': 'Magnetic Stimulation to Treat VT Storm', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm', 'orgStudyIdInfo': {'id': '833561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Patients will receive one hour of sham stimulation.', 'interventionNames': ['Device: Magstim SuperRapid']}, {'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.', 'interventionNames': ['Device: Magstim SuperRapid']}], 'interventions': [{'name': 'Magstim SuperRapid', 'type': 'DEVICE', 'description': 'Transcutaneous magnetic stimulation targeting the left stellate ganglion.', 'armGroupLabels': ['Active']}, {'name': 'Magstim SuperRapid', 'type': 'DEVICE', 'description': 'Sham transcutaneous magnetic stimulation.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}