Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04065802
Status:
UNKNOWN
Last Update Posted:
2022-11-15
First Post:
2019-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-13', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of radiation treatment for VT reduction', 'timeFrame': '6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.', 'description': 'Reduction in VT burden tracked by ICD and defined as the difference between the number of ICD-treated VT/VF episodes comparing the 6 months prior to treatment to the 6 months after treatment.'}, {'measure': 'Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function.', 'timeFrame': '90 days after treatment', 'description': 'Any treatment-related serious adverse events including pericarditis, radiation pneumonitis, deterioration in cardiac function, new or worsening cardiac valve dysfunction, and implantable cardioverter defibrillator malfunction.'}], 'secondaryOutcomes': [{'measure': 'Overall mortality', 'timeFrame': 'Six months', 'description': 'Six month survival after treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stereotactic Radioablation for Ventricular Tachycardia']}, 'referencesModule': {'references': [{'pmid': '29236642', 'type': 'RESULT', 'citation': 'Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.'}, {'pmid': '29694814', 'type': 'RESULT', 'citation': 'Cuculich PS, Robinson CG. Noninvasive Ablation of Ventricular Tachycardia. N Engl J Med. 2018 Apr 26;378(17):1651-1652. doi: 10.1056/NEJMc1802625. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.\n\nSTAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.', 'detailedDescription': 'Study Hypotheses:\n\n1. Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.\n2. STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.\n\nStudy Objectives:\n\n1. Evaluate the safety of STAR in a local cohort\n2. Estimate effectiveness of STAR in reducing VT burden\n\nStudy Design: Prospective single center, single arm, non-randomized trial.\n\nNumber of patients: 20 patients\n\nStudy Duration: Enrollment will occur over three years and at least minimum follow up of six months\n\nStudy Population: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.\n\nPrimary safety endpoint: Any treatment-related serious adverse events in the first 90 days.\n\nPrimary efficacy endpoint: Reduction in VT episodes tracked by ICD with a six week blanking period.\n\nStatistical methodology: Wilcoxon matched-pairs signed-ranks test to compare the number of treated episodes before and after.\n\nAssessment of events: Adjudicated by study investigators\n\nEconomic Analysis: Costs and resources required for STAR .Compare costs between the patients undergoing STAR with conventional catheter-based VT ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18 years of age and have an implanted cardioverter defibrillator (ICD) with:\n\n1. Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.\n2. At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated):\n\nA: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy.\n\nB: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download.\n\nExclusion Criteria:\n\n* Has received prior radiotherapy to the anticipated treatment field\n* Pregnancy\n* Unable to unwilling to provide informed consent\n* New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite\n* Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia.\n* Active coronary ischemia in the last 30 days.'}, 'identificationModule': {'nctId': 'NCT04065802', 'acronym': 'STAR VTM', 'briefTitle': 'Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management', 'orgStudyIdInfo': {'id': 'REB19-1281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radioablation Treatment', 'description': 'Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia', 'interventionNames': ['Radiation: Stereotactic Radioablation']}], 'interventions': [{'name': 'Stereotactic Radioablation', 'type': 'RADIATION', 'description': 'External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias', 'armGroupLabels': ['Radioablation Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jennifer Mckeage', 'role': 'CONTACT', 'email': 'jmckeage@ucalgary.ca', 'phone': '4032106047'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Vikas Kuriachan, MD', 'role': 'CONTACT', 'email': 'vpkuriac@ucalgary.ca', 'phone': '4039443282'}, {'name': 'Stephen Wilton, MD', 'role': 'CONTACT', 'email': 'sbwilton@ucalgary.ca', 'phone': '4032107102'}], 'overallOfficials': [{'name': 'Vikas Kuriachan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be anonymous. Given the small number of patients in the study individual treatments and outcomes maybe looked at.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Libin Cardiovascular Institute of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor (Cardiology/EP)', 'investigatorFullName': 'Vikas Kuriachan', 'investigatorAffiliation': 'University of Calgary'}}}}