[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350706":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":18,"responsibleParty":37,"collaborators":7,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":7,"enrollmentInfo":48,"targetDuration":7,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Philippe CHARRON, MD, PhD","Centre de référence maladies cardiaques héréditaires, Hôpital Ambroise Paré & Hôpital Pitié-Salpêtrière","PRINCIPAL_INVESTIGATOR",[14],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","+ 33 1 49 09 55 43","philippe.charron@aphp.fr",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,","RECRUITING","Boulogne-Billancourt","Hauts-de-Seine","92100","France","FR",{"type":28,"coordinates":29},"Point",[30,31],2.24128,48.83545,{"lat":31,"lon":30},[34],{"name":35,"role":15,"phone":36,"phoneExt":7,"email":17},"Philippe Charron, MD, PhD","+33 1 49 09 55 43",{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100350706","optimisation-of-decision-making-for-defibrillator-implantation-in-hypertrophic-cardiomyopathy-100350706",false,"NCT03846297","Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy","OPTIM-HCM","Inclusion Criteria:\n\n* Patient with a diagnosis of HCM based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions\n* Aged ≥ 16 years\n* Patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention)\n* Affiliation to a social security insurance\n\nExclusion Criteria:\n\n* Specific etiologies such as amyloidosis\n* Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)","ALL","16 Years",{"count":49,"type":50},2000,"ESTIMATED","OBSERVATIONAL","The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imaging (MRI) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk.\n\nThe secondary objective is to perform a medico-economic analysis of ICD implantation in order to define an optimal rule for ICD implantation in patients with HCM, taking into account the benefits of ICD, adverse effects of ICD and associated costs (cost of quality adjusted life years saved).",[54],"Hypertrophic Cardiomyopathy",[56,57],"hypertrophic cardiomyopathy","implantable cardioverter defibrillator","2023-03-15",{"date":60,"type":61},"2023-03-16","ACTUAL",{"date":63,"type":61},"2020-09-23",{"date":65,"type":50},"2027-03",{"name":5,"class":6},1]