[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-pacemaker\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-pacemaker":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,76,96,117],{"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":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100511097","aveir-dr-real-world-evidence-post-approval-study-100511097","NCT05935007","Aveir DR Real-World Evidence Post-Approval Study","Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study","Eligibility Criteria:\n\n* Implanted with an Aveir DR leadless pacemaker\n* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period\n* Ability to link with Medicare fee-for-service data",{"count":56,"type":20},1805,"The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.",[26,59,29],"Arrythmia",[61,62,63,64,65],"bradycardia","sick sinus rhythm","pacemaker","av block","vasovagal syncope","2026-05-18",{"date":68,"type":39},"2026-05-20",{"date":70,"type":39},"2023-10-31",{"date":72,"type":20},"2030-12-31",{"name":74,"class":46},"Abbott Medical Devices",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":75},"100465144","aveir-vr-coverage-with-evidence-development-post-approval-study-100465144","NCT05336877","Aveir VR Coverage With Evidence Development Post-Approval Study","Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study","CED","The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location\n\nInclusion Criteria:\n\nMedicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.\n\nOR\n\nMedicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date\n\nExclusion Criteria:\n\nNone",{"count":85,"type":20},8744,"The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).",[26,59,29],"2025-07-29",{"date":90,"type":39},"2025-07-31",{"date":92,"type":39},"2022-06-21",{"date":94,"type":20},"2028-01-01",{"name":74,"class":46},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":116,"locationsCount":75},"100510912","aveir-dr-coverage-with-evidence-development-ced-study-100510912","NCT05932602","AVEIR DR Coverage With Evidence Development (CED) Study","The AVEIR DR Coverage With Evidence Development (DRIVE) Study","Inclusion Criteria:\n\n* Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.\n\nOR\n\nMedicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date\n\nExclusion Criteria:\n\nNone",{"count":104,"type":20},2812,"The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).",[26,59,29],[108,62,63,109],"dual chamber","AV Block","2025-04-03",{"date":112,"type":39},"2025-04-06",{"date":70,"type":39},{"date":115,"type":20},"2030-05",{"name":74,"class":46},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":75},"100523827","aveir-ar-coverage-with-evidence-development-ced-study-100523827","NCT06100770","Aveir AR Coverage With Evidence Development (CED) Study","ARRIVE","Inclusion Criteria:\n\n1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.\n\n   OR\n2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date\n\nExclusion Criteria:\n\n* None",{"count":125,"type":20},586,"The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).",[26,128,29],"Arrhythmia","2025-04-02",{"date":131,"type":39},"2025-04-04",{"date":133,"type":39},"2024-01-18",{"date":135,"type":20},"2031-01",{"name":74,"class":46}]