[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594316":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":40,"locations":48,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":94,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stereotactic Arrhythmia Radioablation (STAR) procedure","EXPERIMENTAL","In the arm randomized to STAR (alternative experimental therapy), the procedure will involve the elimination of the sVT substrate using ionizing radiation at a dose of 25 Gy, employing highly conformal stereotactic techniques. The STAR procedure will be performed in a radiation oncology department according to a protocol developed by the research team, based on the American Association of Physicists in Medicine (AAPM) report on stereotactic radiotherapy, guidelines for radiotherapy in patients with cardiac implantable electronic devices (CIEDs), and the expert consensus on the implementation and use of STAR in treatment-resistant sVT.",[13],"Radiation: Stereotactic Arrhythmia Radioablation (STAR)",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Catheter Ablation using Radiofrequency Current","ACTIVE_COMPARATOR","In the arm randomized to CA (reference - standard therapy), the procedure will involve the elimination of the sVT substrate using energy transmitted from a generator through a catheter. The CA procedure will be performed in accordance with the expert consensus of the Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), Asia Pacific Heart Rhythm Society (APHRS), and Latin American Heart Rhythm Society (LAHRS) on ventricular arrhythmia ablation.",[19],"Procedure: Catheter Ablation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Stereotactic Arrhythmia Radioablation (STAR)","Radiotherapy Implementation: During treatment on a TrueBeam™ linear accelerator (Varian Medical Systems, Palo Alto, CA, USA), a planned radiation dose of 25 Gy will be delivered to the defined planning target volume (PTV) using highly conformal stereotactic techniques. Image-guided radiotherapy (IGRT), respiratory gating, and Triggered Tracking will be utilized, targeting the previously delineated defibrillation lead of the implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D), with position verification every 15 degrees of gantry rotation.\n\nPatient positioning will be performed using kV-kV imaging, based on pre-determined fiducial markers on the ICD\u002FCRT-D defibrillation lead, followed by verification using gated cone-beam computed tomography (CBCT). Continuous ECG monitoring will be conducted throughout the treatment, and the patient will remain under cardiologist supervision.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Catheter Ablation","CA will be conducted in an electrophysiology laboratory and will routinely follow diagnostic procedures, including an electrophysiological study (EPS) and three-dimensional electroanatomical mapping (3D-EAM). Once sufficient data on the nature and location of the arrhythmic substrate have been obtained from the three primary mapping modules-voltage, activation, and propagation-spatial 3D-EAM maps will be integrated with a 3D left ventricular reconstruction from multislice computed tomography (MSCT) or cardiac magnetic resonance (CMR). Subsequently, ablation will be performed by delivering energy to predefined target sites identified as the arrhythmia source to close the sVT isthmus or eliminate late potentials (LPs) and\u002For low-amplitude ventricular activities (LAVAs). Following CA, a repeat induction attempt of sVT using programmed ventricular pacing (VP) will be conducted to verify procedural efficacy.",[15],[33,37],{"name":34,"affiliation":35,"role":36},"Krzysztof S. Gołba, Professor","Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Ziolowa 45\u002F47, Katowice 40-635, Poland","STUDY_DIRECTOR",{"name":38,"affiliation":35,"role":39},"Danuta Łoboda, MD, PhD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":34,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","+48 32 359 89 90","kgolba@sum.edu.pl",{"name":38,"role":42,"phone":46,"phoneExt":26,"email":47},"+48 32 359 88 93","dloboda@sum.edu.pl",[49],{"facility":50,"status":26,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice","Katowice","Upper-Silesia","40-635","Poland","PL",{"type":57,"coordinates":58},"Point",[59,60],19.02173,50.2597,{"lat":60,"lon":59},[63,65,66],{"name":34,"role":42,"phone":64,"phoneExt":26,"email":44},"+48 32 359 88 90",{"name":38,"role":42,"phone":46,"phoneExt":26,"email":47},{"name":38,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100594316","stereotactic-radiosurgery-as-second-line-therapy-for-ventricular-tachycardia-100594316",false,"NCT07017855","Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia","STAR-4VT","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of enrollment.\n2. Presence of structural heart disease (SHD) of either ischemic or non-ischemic etiology.\n3. Implanted ICD or CRT-D device for primary or secondary prevention of sudden cardiac death (SCD).\n4. History of at least one endocardial CA procedure targeting a substrate of monomorphic sVT.\n5. Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.\n6. Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management.\n7. Provision of written informed consent prior to study participation.\n\nExclusion Criteria:\n\n1. Reversible cause of sVT recurrence, particularly acute coronary syndrome (ACS), acute myocarditis, or lead-related infective endocarditis (LDIE).\n2. Myocardial infarction (MI) or cardiac surgery within the last 40 days.\n3. Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies.\n4. Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved.\n5. Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.\n6. Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.\n7. A mobile thrombus within the left ventricle (LV).\n8. Presence of a left ventricular assist device (LVAD).\n9. Presence of comorbidities or known risk factors for CA complications that, in the judgment of the electrophysiologist, constitute a contraindication to the procedure for safety reasons.\n10. Active, uncontrolled malignancy and\u002For chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure.\n11. Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months.\n12. Presence of comorbidities or known risk factors for radiotherapy complications that, in the judgment of the radiation oncologist, constitute a contraindication to STAR for safety reasons.\n13. Pregnancy or breastfeeding.\n14. Systemic disease that limits the probability of survival to less than 1 year\n15. Other comorbidities, addictions, or social indications that, in the investigator's opinion, would preclude practical cooperation or otherwise disqualify the patient from participation in the clinical study.\n16. Refusal to participate or lack of written informed consent for study participation.","ALL","18 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"NA","The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).",[86,87,88,89,90,91,92,93],"Ventricular Tachycardia, Monomorphic","Ventricular Tachycardia, Sustained","Ventricular Tachycardia (VT)","Ventricular Tachycardia (V-Tach)","Stereotactic Body Radiation Therapy (SBRT)","Stereotactic Techniques","Stereotactic Radiation","Cardioverter-Defibrillators, Implantable",[95,96,97,98,99,100],"Ventricular Tachycardia","VT","Stereotactic Arrhythmia Radioablation","STAR","Implanted Cardioverter-Defibrillator","ICD","NOT_YET_RECRUITING","2025-06-04",{"date":104,"type":105},"2025-06-12","ACTUAL",{"date":107,"type":80},"2025-07-01",{"date":109,"type":80},"2028-11-01",{"name":5,"class":6},1]