[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640189":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":43,"collaborators":22,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":22,"enrollmentInfo":57,"targetDuration":22,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":22,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Southlake Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"STAR (Stereotactic Arrhythmia Radioablation)","EXPERIMENTAL","Single 25 Gy fraction of VMAT-based stereotactic body radiotherapy delivered to the arrhythmogenic substrate identified by cardiac CT, 12-lead ECG of the clinical arrhythmia, and (where available) non-invasive electrocardiographic mapping or electroanatomical mapping. In selected cases with large planning target volumes or proximity to organs at risk, the dose may be delivered in 2 fractions 24-48 hours apart. Participants are followed for 12 months for arrhythmia outcomes and radiation toxicity.",[13],"Radiation: Stereotactic Arrhythmia Radioablation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Stereotactic Arrhythmia Radioablation","Single fraction of 25 Gy stereotactic body radiotherapy (SBRT) delivered using a volumetric modulated arc therapy (VMAT) technique with 6 MV FFF photons on an Elekta Agility linear accelerator. The clinical target volume (arrhythmogenic scar) is delineated by the radiation oncologist and electrophysiologist using cardiac CT, 12-lead ECGs of the clinical arrhythmia, and (where available) non-invasive electrocardiographic mapping (252-electrode CardioInsight vest) and\u002For 3-D electroanatomical mapping. A 4D-CT simulation accounts for cardiac and respiratory motion. In selected cases with a large planning target volume or proximity to critical organs at risk (stomach, esophagus, spinal cord), the dose may be delivered in 2 fractions 24-48 hours apart. Treatment is delivered with image guidance (cone-beam CT) on the day of treatment. Total dose: 25 Gy in 1 or 2 fractions.",[9],[21],"Cardiac SBRT",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Mouhannad Sadek, MD","CONTACT","905-895-4521","msadek@southlake.ca",[30],{"facility":31,"status":22,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":22},"Southlake Regional Health Centre","Newmarket","Ontario","L3Y 2P9","Canada","CA",{"type":38,"coordinates":39},"Point",[40,41],-79.46631,44.05011,{"lat":41,"lon":40},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Mouhannad Sadek","Principal Investigator","100640189","stereotactic-radioablation-as-first-line-therapy-for-scar-related-ventricular-tachycardia-100640189",false,"NCT07618780","Stereotactic Radioablation as First-Line Therapy for Scar-Related Ventricular Tachycardia","Stereotactic Arrhythmia Radioablation as First-Line Treatment for Scar-Related Ventricular Tachycardia","START-VT","Inclusion Criteria:\n\n* Age 18 years or older and able to provide informed consent\n* Structural heart disease with myocardial fibrosis identified on pre-procedural imaging, including imaging evidence of regional myocardial akinesis\u002Fthinning or documented scar on echocardiography, cardiac CT, or cardiac MRI\n* Sustained monomorphic ventricular tachycardia (symptomatic or requiring ICD shocks for termination) within the previous 6 months\n\nExclusion Criteria:\n\n* Reversible causes of VT (e.g., active ischemia, drug-induced, electrolyte abnormalities)\n* Acute coronary syndrome within 30 days, coronary revascularization (\\\u003C90 days for bypass surgery, \\\u003C30 days for percutaneous coronary intervention)\n* Patients previously treated with high-dose radiotherapy that precludes safe delivery of thoracic stereotactic radiotherapy (relative contraindication)\n* Patients requiring chest radiotherapy for an active cancer (relative contraindication)\n* VT targets cannot be identified or are not suitable for targeting with stereotactic radiotherapy (such as multiple foci of arrhythmia)\n* Patients who cannot tolerate the radiotherapy treatment position, or whose body habitus is not permissible by treatment bed requirements\n* Pregnant or breast-feeding women\n* Patients being considered for cardiac transplant who are deemed not eligible by their transplant team for STAR","ALL","18 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"NA","Ventricular tachycardia (VT) is a dangerous fast heart rhythm originating from scarred areas of the heart muscle, often after a heart attack or in patients with cardiomyopathy. Patients with VT and structural heart disease typically receive an implantable cardioverter-defibrillator (ICD) to prevent sudden death. Despite the ICD, recurrent VT and ICD shocks remain common and are associated with poor quality of life. Current preventive therapies - antiarrhythmic medications and catheter radiofrequency ablation - have important limitations including side effects, incomplete effectiveness, and procedural risk.\n\nStereotactic Arrhythmia Radioablation (STAR) is a non-invasive treatment in which a single, precisely targeted dose of radiation is delivered to the scar tissue that gives rise to the abnormal heart rhythm. STAR has previously been studied in patients who have failed catheter ablation or are too high risk for that procedure, with promising results. However, STAR has not been formally evaluated as a first-line treatment.\n\nThis single-arm prospective feasibility study will enroll 20 adults with structural heart disease and sustained monomorphic VT. Each participant will receive a single 25 Gy fraction of stereotactic body radiotherapy (VMAT technique) targeted at the arrhythmogenic substrate identified by cardiac imaging, 12-lead ECG, and (where available) non-invasive electrocardiographic mapping or electroanatomical mapping. Participants will be followed at 6 weeks, 3, 6, 9, and 12 months to assess the primary efficacy outcomes (death, appropriate ICD shock, VT storm, and sustained VT below ICD detection rate after a 6-week blanking period) and safety outcomes (acute heart failure decompensation, drop in left ventricular ejection fraction, and STAR-specific toxicities such as pneumonitis, esophagitis, and pericarditis). The hypothesis is that STAR delivered as first-line therapy is safe and effective, with a comparable toxicity and efficacy profile to catheter radiofrequency ablation.",[65,66],"Ventricular Tachycardia, Monomorphic","Cardiomyopathies",[68,69,70,71,72],"Stereotactic Body Radiotherapy","Cardiac Radioablation","Radioablation","Implantable Cardioverter Defibrillator","STAR-VT","NOT_YET_RECRUITING","2026-05-24",{"date":76,"type":77},"2026-06-01","ACTUAL",{"date":79,"type":59},"2026-07",{"date":81,"type":59},"2029-07",{"name":5,"class":6},1]