[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492624":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"MicroPort CRM","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Pacemaker system",null,"Patients implanted with ENO or ALIZEA family pacing systems",[13],"Device: Implantation of a CIED",{"label":15,"type":10,"description":16,"interventionNames":17},"ICD system","Patients implanted with ULYS family ICD systems",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"CRT-D system","Patients implanted with GALI family CRT-D systems",[13],[23],{"type":24,"name":25,"description":25,"armGroupLabels":26,"otherNames":10},"DEVICE","Implantation of a CIED",[19,15,9],[28],{"name":29,"affiliation":5,"role":30},"Yann POEZEVARA, MSc","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Hanan FAWAZ, MSC","CONTACT","33616531960","hanan.fawaz@crm.microport.com",[38],{"facility":39,"status":40,"city":41,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital Santa Marta Lisboa","RECRUITING","Lisbon","Portugal","PT",{"type":45,"coordinates":46},"Point",[47,48],-9.1498,38.72509,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":10,"phoneExt":10,"email":10},"Mario Olivera, MD",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100492624","post-market-surveillance-of-micorport-crm-cardiac-implantable-electronic-devices-100492624",false,"NCT05694572","Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices","PIANO","Inclusion Criteria:\n\nSubjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:\n\n1. Subject implanted with one of the following MicroPort CRM market-released system:\n\n   * ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead\n   * ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.\n   * GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.\n   * GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.\n   * Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead\n2. Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)\n3. Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system\n4. Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are not eligible to be enrolled in the study:\n\n1. Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention\n2. Life expectancy less than 1 year\n3. Currently enrolled in an active study of MicroPort CRM","ALL","18 Years","90 Years",{"count":66,"type":67},2500,"ESTIMATED","5 Years","OBSERVATIONAL","The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.",[72,73,74],"Cardiac Rhythm Disorder","Heart Failure","Sudden Cardiac Death","2024-01-12",{"date":77,"type":78},"2024-01-17","ACTUAL",{"date":80,"type":78},"2023-10-30",{"date":82,"type":67},"2031-06-15",{"name":5,"class":6},1]