[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572897":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":30,"responsibleParty":48,"collaborators":52,"id":148,"slug":10,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":10,"maxAge":10,"enrollmentInfo":155,"targetDuration":158,"studyType":159,"phases":10,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Paris Sudden Death Expertise Center","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"All patients implanted with EV-ICD in France",null,[12],"Device: Extra-Vascular Implantable Cardioverter Defibrillator",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Extra-Vascular Implantable Cardioverter Defibrillator","The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.",[9],[20,26],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Eloi MARIJON, MD, PhD","CONTACT","662833848","+33","eloi.marijon@aphp.fr",{"name":27,"role":22,"phone":28,"phoneExt":24,"email":29},"Fawzi KERKOURI, MD, MPH","7 67 14 95 58‬","eecmcfawzikerkouri@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"European Georges Pompidou Hospital","RECRUITING","Paris","75015","France",{"type":38,"coordinates":39},"Point",[40,41],2.3488,48.85341,{"lat":41,"lon":40},[44],{"name":45,"role":22,"phone":46,"phoneExt":47,"email":25},"Eloi Marijon, Head of Cardiology Department","+33 6 62 83 38 48","+33 1 56 09 30",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":32,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Marijon","Head of Cardiology Division",[53,54,56,58,60,62,64,66,68,70,72,74,77,79,81,83,85,87,89,91,93,95,97,99,101,103,105,107,109,111,113,115,117,119,121,123,125,127,129,132,134,136,138,140,142,144,146],{"name":32,"class":6},{"name":55,"class":6},"University Hospital, Grenoble",{"name":57,"class":6},"University Hospital, Clermont-Ferrand",{"name":59,"class":6},"University Hospital, Rouen",{"name":61,"class":6},"Centre Hospitalier Universitaire de Besancon",{"name":63,"class":6},"Clinique du Millenaire",{"name":65,"class":6},"Institut Mutualiste Montsouris",{"name":67,"class":6},"Groupe Hospitalier Pitie-Salpetriere",{"name":69,"class":6},"University Hospital, Lille",{"name":71,"class":6},"University Hospital, Caen",{"name":73,"class":6},"Hospices Civils de Lyon",{"name":75,"class":76},"CHU de la Timone, Marseille, France","UNKNOWN",{"name":78,"class":76},"Centre Cardio-Thoracique de Monaco",{"name":80,"class":76},"Hospital of Lens",{"name":82,"class":6},"Institute Arnault Tzanck, France",{"name":84,"class":6},"University Hospital, Strasbourg, France",{"name":86,"class":6},"University Hospital, Limoges",{"name":88,"class":6},"University Hospital, Montpellier",{"name":90,"class":6},"Clinique Pasteur Toulouse",{"name":92,"class":6},"University Hospital, Bordeaux",{"name":94,"class":6},"University Hospital, Toulouse",{"name":96,"class":76},"Institut Jacques Cartier - Massy",{"name":98,"class":76},"Clinique Saint Augustin - Bordeaux",{"name":100,"class":6},"Rennes University Hospital",{"name":102,"class":6},"Clinique de la Sauvegarde",{"name":104,"class":6},"University Hospital of Saint-Etienne",{"name":106,"class":6},"Centre Hospitalier Universitaire, Amiens",{"name":108,"class":6},"Poitiers University Hospital",{"name":110,"class":76},"Clinique Saint-Gatien - Tours",{"name":112,"class":6},"CHU de Reims",{"name":114,"class":6},"Centre Hospitalier Universitaire Dijon",{"name":116,"class":6},"Hospital St. Joseph, Marseille, France",{"name":118,"class":6},"Centre Hospitalier Annecy Genevois",{"name":120,"class":76},"Clinique St Pierre, Perpignan, France",{"name":122,"class":6},"Bichat Hospital",{"name":124,"class":6},"Universite de La Reunion",{"name":126,"class":6},"University Hospital Center of Martinique",{"name":128,"class":6},"Henri Mondor University Hospital",{"name":130,"class":131},"University Hospital, Angers","OTHER_GOV",{"name":133,"class":6},"Central Hospital, Nancy, France",{"name":135,"class":76},"Hôpital privé Clairval - Marseille",{"name":137,"class":6},"Médipôle Lyon-Villeurbanne",{"name":139,"class":6},"Hôpital Privé Les Franciscaines",{"name":141,"class":6},"Hospital Ambroise Paré Paris",{"name":143,"class":76},"Central Hospital, Metz Thionville, France",{"name":145,"class":76},"Hopital Prive Saint Martin - Bordeaux",{"name":147,"class":6},"Hôpital Privé de Parly II - Le Chesnay","100572897",false,"NCT06739239","French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR","FOREVER","Inclusion Criteria:\n\n* All patients undergoing EV-ICD implantation\n\nExclusion Criteria:\n\n* Refusal of consent","ALL",{"count":156,"type":157},1000,"ESTIMATED","5 Years","OBSERVATIONAL","Implantable cardioverter-defibrillators (ICDs) are widely recognized for their efficacy in reducing the risk of sudden cardiac death in high-risk patients. Nonetheless, there remains significant scope for improving outcomes through advancements in device technology and design. The extravascular cardioverter-defibrillator (EV-ICD) represents such an innovation, offering key advantages over other ICD systems. It incorporates a lead positioned in the substernal space, enabling the delivery of pause-prevention security pacing, antitachycardia pacing, and defibrillation energy similar to that provided by conventional transvenous ICDs.\n\nPrevious studies have demonstrated that EV-ICDs can be implanted safely and are capable of terminating majority of induced ventricular arrhythmias during implantation; however, follow-up data are limited to highly experienced selected centers and over a relatively small follow-up period (6-month follow-up). The FOREVER cohort study, initiated by the French Institute of Health and Medical Research, aims to evaluate the EV-ICD use in France.\n\nThis nationwide evaluation will provide an exhaustive collection of all EV-ICD implantations in France, offering valuable real-world evidence on the long-term safety and efficacy of the device.",[162,163],"Defibrillators, Implantable","Sudden Cardiac Death Due to Cardiac Arrhythmia",[165,166,167],"Implantable cardioverter defibrillator","sudden cardiac death","Extravascular Implantable Cardioverter-Defibrillator","2024-12-17",{"date":170,"type":171},"2024-12-20","ACTUAL",{"date":173,"type":171},"2024-02-01",{"date":175,"type":157},"2030-12-31",{"name":5,"class":6},1]