[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"implantable-cardioverter-defibrillator\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:implantable-cardioverter-defibrillator":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100623159","biostreamcsp-study-100623159",false,"NCT07393009","BIO|STREAM.CSP Study","Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)","Inclusion Criteria:\n\n* Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P\u002F-D)\n* Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO\\|MASTER.CSP study\n* Ability to understand the nature of the study\n* Ability and willingness to perform all follow-up visits\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept\n\nExclusion Criteria:\n\n* Planned dation from intended use\n* Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment\n* Life-expectancy less than 12 months\n* Pregnant or breast feeding\n* Age less than 18 years\n* Participation in an interventional clinical investigation, except for submodules within this study.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","4 Years","OBSERVATIONAL","The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.",[25,26,27,28,29,30,31],"Cardiac Pacing","Cardiac Pacemaker","Implantable Cardioverter Defibrillator","Cardiac Resynchronization Therapy Devices","Bradycardia","Tachycardia","Heart Failure",[33,34],"Conduction system pacing (CSP)","Left bundle branch area pacing (LBBAP)","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2026-05-25",{"date":43,"type":20},"2033-02-01",{"name":45,"class":46},"Biotronik SE & Co. KG","INDUSTRY",40,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100467989","cardioverter-defibriilator-placement-for-primary-prevention-of-sudden-cardiac-death-in-patients-older-than-70-years-100467989","NCT05373940","Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years","Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial","DILEMMA","Inclusion Criteria:\n\n* ≥70 years old,\n* Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and\u002For cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).\n* NYHA class II or III\n* Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)\n* Providing informed consent\n* Affiliated to a French Health Insurance system.\n\nExclusion Criteria:\n\n* Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)\n* Prior unstable sustained ventricular arrhythmia requiring external cardioversion\n* Myocardial infarction within the 40 days\n* Coronary artery intervention (catheter or surgical) within 90 days\n* History of syncope in the previous 6 months\n* Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy)\n* Cognitive impairment leading to the incapacity of consent\n* Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.\n* Patient under tutorship, curatorship, or legal safeguard\n* Persons deprived of their liberty by judicial or administrative decision (prisoner)","70 Years",{"count":58,"type":20},730,"INTERVENTIONAL",[61],"NA","The primary objective of DILEMMA study is to assess whether the \"heart failure optimal therapy alone (HFOT)\" strategy is non inferior to the \"HFOT+ICD\" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.",[31,64,27],"Primary Prevention of Sudden Cardiac Death",[31,66,67,68,69],"Prevention strategy of Sudden Cardiac Death","Implantable cardioverter defibrillator","Heart Failure Optimal Therapy","Mortality","2026-03-23",{"date":72,"type":39},"2026-03-24",{"date":74,"type":39},"2022-06-29",{"date":76,"type":20},"2030-05-31",{"name":78,"class":79},"Assistance Publique - Hôpitaux de Paris","OTHER",19,"Implantable Cardioverter-Defibrillator"]