[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575220":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":80,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Azienda Sanitaria Universitaria Integrata del Trentino","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiosurgical ablation of a tachyarrhytmogenic substrate with Proton Therapy","EXPERIMENTAL","Ablation of the arrhythmogenic substrate with a single dose of 25Gy(RBE) with Proton Therapy after pretreatment diagnostics with CT, MR and electrophysiology for the definition of the arrhytmogenic substrate. Follow-up for 24 months after treatment.",[13],"Radiation: Stereotactic Arrhythmia Radioablation (STAR) with Proton Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Stereotactic Arrhythmia Radioablation (STAR) with Proton Therapy","STAR with a single dose of 25Gy(RBE) Proton Therapy",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Maurizio Del Greco, M.D.","CONTACT","+390464403312","maurizio.delgreco@apss.tn.it",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Frank RH Lohr, M.D.","+3904611953100","frank.lohr@apss.tn.it",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":35,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cardiology Rovereto and Proton Therapy Trento, Azienda Provinciale per i Servizi Sanitari (APSS)","Trento","Italy","38123","IT",{"type":39,"coordinates":40},"Point",[41,42],11.12108,46.06787,{"lat":42,"lon":41},[45,46,47],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":48,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":6},"Università degli Studi di Trento","100575220","proton-radiosurgery-for-the-treatment-of-malignant-ventricular-tachyarrhythmias-100575220",false,"NCT06769451","Proton Radiosurgery for the Treatment of Malignant Ventricular Tachyarrhythmias","Radiosurgery With proTOns for the Treatment of VEntricular maLignant Tachyarrhytmias (TOVEL Study)","TOVEL","Inclusion Criteria:\n\n1. age ≥ 40 years\n2. carrier of ICD\u002FCRT-D or S-ICD\n3. episodes of ventricular tachycardia\u002Fventricular fibrillation requiring defibrillator intervention (shock or ATP) which are:\n\n   * refractory to maximal drug therapy;\n   * recurrent (at least 3 episodes in the previous 6 months);\n4. patients with contraindications to a conventional ablative strategy, in relation to the high risk associated with the procedure due to the severity of the heart disease and\u002For the presence of comorbidities or patients who have already undergone ablation, in the presence of an arrhythmogenic substrate refractory to or unsuitable for an interventional approach or patients who refuse transcatheter ablative attempts due to high intraoperative risk in relation to the patient's characteristics.\n5. Left ventricular ejection fraction ≥ 20%.\n\nExclusion Criteria:\n\n1. inability to express informed consent\n2. previous thoracic radiotherapy (RT) with cardiac involvement\n3. active myocardial ischemia\n4. recent cardiac revascularization (\\\u003C 120 days)\n5. hemodynamic instability (cardiogenic shock, NYHA class IV)\n6. contraindication to radiosurgery (e.g., due to artifacts or other technical reasons)\n7. lack of patient cooperation in pre-procedural investigations\n8. ICD malfunction\n9. severe comorbidity with prognosis \\\u003C 12 months\n10. pregnancy","ALL","40 Years",{"count":65,"type":66},21,"ESTIMATED","INTERVENTIONAL",[69],"NA","Ventricular arrhythmias (VAs) are the leading cause of sudden cardiac death (SCD) worldwide. The implantable defibrillator (ICD) increases survival in patients at risk of VA, with data of superiority to antiarrhythmic drugs. Nevertheless, the ICD cannot prevent VAs, and shocks delivered by the device (appropriate and inappropriate) negatively impact patients' quality of life. Transcatheter ablation (TCA) is the percutaneous therapy that can eliminate VAs and prevent any recurrence. TCA is the state of the art for the treatment of drug-unresponsive VAs in patients with structural heart disease, but the prevalence of recurrence remains high (between 30% and 60%). For these reasons, several reports have recently appeared in the literature proposing a new solution for the treatment of VAs in which the use of external-beam body radiotherapy with stereotactic-radiosurgical technique (SBRT) is described. SBRT represents a rapid, noninvasive approach based on the delivery of high radiation doses of photons (25 Gy in a single fraction) to a precise location in cardiac tissue.\n\nSBRT has entered the latest 2022 European Society of Cardiology (ESC) guidelines on VAs as a \"bailout therapy\". Based on preliminary data in the oncology setting, proton therapy could allow further optimization of compliance of these therapeutic doses by preserving even more of the healthy heart part and thus reducing the cardiopulmonary toxicity of radiotherapy outside the ablation target.\n\nThe investigators therefore propose an experimental (prospective interventional) study to evaluate the toxicity (primary endpoint) and efficacy (secondary endpoint) of proton radiosurgery for the treatment of VA with an enrollment of 21 patients. The primary endpoint is to evaluate the toxicity of proton radiotherapy in the acute phase (during the first 30 days of the procedure) and at 3, 6 and 12 months. A crucial part of the protocol will be the proper definition of the target to be irradiated, which will require the integration of different non-invasive cardiac imaging methodologies such as CT (Computed Tomography), MRI (Magnetic Resonance Imaging) and PET (Positron Emission Tomography), coupled with invasive and\u002For \"non-invasive\" body surface mapping with multi-electrode electrocardiogram (ECG) so as to obtain a \"cardiac image\" in which the myocardial scar and the arrhythmogenic region are fused.",[72,73],"Ventricular Arrhythmia","Ventricular Tachycardia (V-Tach)",[75,76,77,78,79],"Stereotactic arrhythmia radioablation (STAR)","Malignant ventricular Tachycardia","Ventricular Tachycardia Storm","Radiotherapy","Proton Therapy","NOT_YET_RECRUITING","2025-01-23",{"date":83,"type":84},"2025-01-27","ACTUAL",{"date":86,"type":66},"2025-02",{"date":88,"type":66},"2030-02",{"name":5,"class":6},1]