[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572897":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":30,"responsibleParty":49,"collaborators":53,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":10,"maxAge":10,"enrollmentInfo":157,"targetDuration":160,"studyType":161,"phases":10,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"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,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"European Georges Pompidou Hospital","RECRUITING","Paris","75015","France","FR",{"type":39,"coordinates":40},"Point",[41,42],2.3488,48.85341,{"lat":42,"lon":41},[45],{"name":46,"role":22,"phone":47,"phoneExt":48,"email":25},"Eloi Marijon, Head of Cardiology Department","+33 6 62 83 38 48","+33 1 56 09 30",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":32,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Marijon","Head of Cardiology Division",[54,55,57,59,61,63,65,67,69,71,73,75,78,80,82,84,86,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116,118,120,122,124,126,128,130,133,135,137,139,141,143,145,147],{"name":32,"class":6},{"name":56,"class":6},"University Hospital, Grenoble",{"name":58,"class":6},"University Hospital, Clermont-Ferrand",{"name":60,"class":6},"University Hospital, Rouen",{"name":62,"class":6},"Centre Hospitalier Universitaire de Besancon",{"name":64,"class":6},"Clinique du Millenaire",{"name":66,"class":6},"Institut Mutualiste Montsouris",{"name":68,"class":6},"Groupe Hospitalier Pitie-Salpetriere",{"name":70,"class":6},"University Hospital, Lille",{"name":72,"class":6},"University Hospital, Caen",{"name":74,"class":6},"Hospices Civils de Lyon",{"name":76,"class":77},"CHU de la Timone, Marseille, France","UNKNOWN",{"name":79,"class":77},"Centre Cardio-Thoracique de Monaco",{"name":81,"class":77},"Hospital of Lens",{"name":83,"class":6},"Institute Arnault Tzanck, France",{"name":85,"class":6},"University Hospital, Strasbourg, France",{"name":87,"class":6},"University Hospital, Limoges",{"name":89,"class":6},"University Hospital, Montpellier",{"name":91,"class":6},"Clinique Pasteur Toulouse",{"name":93,"class":6},"University Hospital, Bordeaux",{"name":95,"class":6},"University Hospital, Toulouse",{"name":97,"class":77},"Institut Jacques Cartier - Massy",{"name":99,"class":77},"Clinique Saint Augustin - Bordeaux",{"name":101,"class":6},"Rennes University Hospital",{"name":103,"class":6},"Clinique de la Sauvegarde",{"name":105,"class":6},"University Hospital of Saint-Etienne",{"name":107,"class":6},"Centre Hospitalier Universitaire, Amiens",{"name":109,"class":6},"Poitiers University Hospital",{"name":111,"class":77},"Clinique Saint-Gatien - Tours",{"name":113,"class":6},"CHU de Reims",{"name":115,"class":6},"Centre Hospitalier Universitaire Dijon",{"name":117,"class":6},"Hospital St. Joseph, Marseille, France",{"name":119,"class":6},"Centre Hospitalier Annecy Genevois",{"name":121,"class":77},"Clinique St Pierre, Perpignan, France",{"name":123,"class":6},"Bichat Hospital",{"name":125,"class":6},"Universite de La Reunion",{"name":127,"class":6},"University Hospital Center of Martinique",{"name":129,"class":6},"Henri Mondor University Hospital",{"name":131,"class":132},"University Hospital, Angers","OTHER_GOV",{"name":134,"class":6},"Central Hospital, Nancy, France",{"name":136,"class":77},"Hôpital privé Clairval - Marseille",{"name":138,"class":6},"Médipôle Lyon-Villeurbanne",{"name":140,"class":6},"Hôpital Privé Les Franciscaines",{"name":142,"class":6},"Hospital Ambroise Paré Paris",{"name":144,"class":77},"Central Hospital, Metz Thionville, France",{"name":146,"class":77},"Hopital Prive Saint Martin - Bordeaux",{"name":148,"class":6},"Hôpital Privé de Parly II - Le Chesnay","100572897","french-cohorte-extra-vascular-implantable-cardioverter-defibrillator-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":158,"type":159},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.",[164,165],"Defibrillators, Implantable","Sudden Cardiac Death Due to Cardiac Arrhythmia",[167,168,169],"Implantable cardioverter defibrillator","sudden cardiac death","Extravascular Implantable Cardioverter-Defibrillator","2024-12-17",{"date":172,"type":173},"2024-12-20","ACTUAL",{"date":175,"type":173},"2024-02-01",{"date":177,"type":159},"2030-12-31",{"name":5,"class":6},1]