Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT03349892
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia
Sponsor:
Organization:
Raw JSON
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[{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Ablation Treatment Arm', 'description': 'This is a single-arm, non-blinded study.\n\nStereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.'}], 'timeFrame': '5 years', 'description': 'Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participant was lost to follow-up prior to 5-year assessment'}, {'type': 'SECONDARY', 'title': 'Incidence of ICD Shocks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Ablation Treatment Arm', 'description': 'This is a single-arm, non-blinded study.\n\nStereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post-SABR procedure', 'description': 'Incidence of ICD shocks 12 months post-SABR procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject was followed for 28 months.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Ablation Treatment Arm', 'description': 'This is a single-arm, non-blinded study.\n\nStereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.'}], 'timeFrame': '5 years', 'description': 'Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject was not followed for 5 years'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Ablation Treatment Arm', 'description': 'This is a single-arm, non-blinded study.\n\nStereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.'}], 'timeFrame': '5 years', 'description': 'Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of \\>3 months over 5 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject was not followed for 5 years'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Steroid Use for Radiotherapy Related Indications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Ablation Treatment Arm', 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Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Documented sustained ventricular arrhythmias refractory to or not suitable for cardiac transplantation, cardiac sympathetic denervation therapy, catheter based RFA ablative therapy or other medical management.'}}, 'documentSection': 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'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-15', 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms', 'timeFrame': '5 years', 'description': 'Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years'}, {'measure': 'Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months', 'timeFrame': '5 years', 'description': 'Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of \\>3 months over 5 years'}, {'measure': 'Incidence of Steroid Use for Radiotherapy Related Indications', 'timeFrame': '5 years'}, {'measure': 'Overall Survival', 'timeFrame': 'Followed for 10 years +'}], 'primaryOutcomes': [{'measure': 'ICD (Implantable Cardioverter Defibrillator) Shock Free Survival', 'timeFrame': '6 months', 'description': 'ICD (implantable cardioverter defibrillator) shock free survival at six months'}, {'measure': 'Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)', 'timeFrame': '5 years', 'description': 'Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital', 'timeFrame': '5 years', 'description': 'Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years'}, {'measure': 'Incidence of ICD Shocks', 'timeFrame': '12 months post-SABR procedure', 'description': 'Incidence of ICD shocks 12 months post-SABR procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractory Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDocumented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy\n\n* Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy\n* Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation\n* Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management\n* ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias\n* If ischemic cardiomyopathy, myocardial infarction occurred more than one month prior to enrollment\n* No history of prior radiotherapy to the chest\n* Prescribed dose must be deliverable using SABR technique\n* Age ≥ 18 years\n* Karnofsky Performance Status (KPS) \\> 70\n* If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment.\n* Ability to understand and willingness to sign a written informed consent'}, 'identificationModule': {'nctId': 'NCT03349892', 'briefTitle': 'Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study', 'orgStudyIdInfo': {'id': 'Cardiac SABR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic Ablation Treatment Arm', 'description': 'This is a single-arm, non-blinded study.', 'interventionNames': ['Radiation: Stereotactic Ablative Radiotherapy (SABR)']}], 'interventions': [{'name': 'Stereotactic Ablative Radiotherapy (SABR)', 'type': 'RADIATION', 'otherNames': ['external beam radiation'], 'description': 'A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.', 'armGroupLabels': ['Stereotactic Ablation Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6951', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Department of Radiation Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert K. Chin', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}