[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538683":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":66,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,15],{"label":9,"type":10,"description":9,"interventionNames":11},"Implantation of an automatic defibrillator","ACTIVE_COMPARATOR",[12,13,14],"Other: Adverse events collection","Other: Quality of life questionnaire EQ-5D-5L","Other: Medical-economic evaluation",{"label":16,"type":17,"description":16,"interventionNames":18},"Percutaneous catheter ablation","EXPERIMENTAL",[12,13,14],[20,25,29],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Adverse events collection","Collection of deaths from any cause, hospitalizations or emergency consultations for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)",[9,16],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Quality of life questionnaire EQ-5D-5L","Questionnaire on the patient's quality of life and health in 6 questions: on mobility, the person's autonomy, current activities, pain, anxiety. Answers range from \"no problem\" to \"unable\" and 5 possible answers to each question.\n\nThe last question concerns the patient's health, the patient must rate his or her health on a scale of 0 to 100",[9,16],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Medical-economic evaluation","Collection of expenses incurred by the care of patients in each arm will be collected over a period of 36 months.\n\nDirect medical and non-medical costs as well as costs related to absences from the workplace will be included in the analysis. Healthcare consumption will be collected using the National Health Data System (SNDS).",[9,16],[34],{"name":35,"affiliation":5,"role":36},"Philippe MAURY, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","5 61 34 10 18","+33","maury.p@chu-toulouse.fr",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Audrey TOMASIK","5 61 77 85 97","tomasik.a@chu-toulouse.fr",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":52,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Rangueil Hospital","RECRUITING","Toulouse","France","31059","FR",{"type":56,"coordinates":57},"Point",[58,59],1.44367,43.60426,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":64,"phoneExt":41,"email":65},"Philippe MD MAURY","561341018","maury.p@chu-touloue.fr",{"type":67,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100538683","international-multicenter-project-comparing-radiofrequency-ablation-versus-implantable-defibrillator-after-well-tolerated-ventricular-tachycardia-in-ischemic-heart-disease-with-minimally-impaired-ejection-fraction-100538683",false,"NCT06294028","International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction","VIVA","Inclusion Criteria:\n\n* ischemic heart disease with history of infarction - LVEF\\> 35% (measured by MRI)\n* sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -\n* having signed informed consent\n* affiliated to a social security system\n\nExclusion Criteria:\n\n* transient regressive cause of ventricular tachycardia\n* recent myocardial infarction (\\\u003C2 months)\n* ventricular tachycardia by reentry from branch to branch\n* serious conduction disturbances (with indication of stimulation)\n* contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy \\\u003C1 year, relevant comorbidities)\n* pregnancy\n* age \\\u003C18 years\n* Patient under legal protection, guardianship or curatorship","ALL","18 Years","90 Years",{"count":79,"type":80},268,"ESTIMATED","INTERVENTIONAL",[83],"NA","Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.\n\nOn the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.\n\nFinally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.",[86,87],"Ischemic Heart Disease","Ventricular Tachycardia",[89],"Ablation","2026-05-28",{"date":92,"type":93},"2026-06-01","ACTUAL",{"date":95,"type":93},"2024-06-12",{"date":97,"type":80},"2029-12-31",{"name":5,"class":6},1]