[{"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,6,0,[8,48,79,105,125,146],{"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":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100615040","leap-2-chronic-efs-100615040",false,"NCT07287423","LEAP 2 Chronic EFS","LEadless Advanced Pacing 2 Chronic Early Feasibility Study","Inclusion Criteria:\n\n1. Subject must have at least one standard pacemaker indication\n2. Subject must be at least 18 years of age\n3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams\n4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC\n\nExclusion Criteria:\n\n1. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter\n2. Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure\n3. Subject has previous myocardial infarction\n4. Subject is expected to be pacemaker dependent\n5. Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)\n6. Subject has an active implantable electronic device that cannot be turned off during the study procedure\n7. Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment\n8. Subject has known allergy or hypersensitivity to \\\u003C 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure\n9. Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation\n10. Subject has known chronic renal insufficiency including patients on dialysis\n11. Subject has an active systemic infection\n12. Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect\n13. Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation\n14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period\n15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements of the clinical investigation\n16. Subject is unable to read or write","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.",[26,27,28],"Cardiac Pacemaker","Cardiac Rhythm Disorder","Bradycardia",[28,30,31,32,33,34],"Sick Sinus Syndrome","Pacemaker","Leadless","Conduction System Pacing","LBBAP","RECRUITING","2026-07-14",{"date":38,"type":39},"2026-07-15","ACTUAL",{"date":41,"type":39},"2025-12-13",{"date":43,"type":20},"2028-12",{"name":45,"class":46},"Abbott Medical Devices","INDUSTRY",1,{"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":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100623159","biostreamcsp-study-100623159","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.",{"count":56,"type":20},1000,"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.",[61,26,62,63,28,64,65],"Cardiac Pacing","Implantable Cardioverter Defibrillator","Cardiac Resynchronization Therapy Devices","Tachycardia","Heart Failure",[67,68],"Conduction system pacing (CSP)","Left bundle branch area pacing (LBBAP)","2026-06-24",{"date":71,"type":39},"2026-06-29",{"date":73,"type":39},"2026-05-25",{"date":75,"type":20},"2033-02-01",{"name":77,"class":46},"Biotronik SE & Co. KG",40,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":47},"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":87,"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.",[26,90,28],"Arrythmia",[92,93,94,95,96],"bradycardia","sick sinus rhythm","pacemaker","av block","vasovagal syncope","2026-05-18",{"date":99,"type":39},"2026-05-20",{"date":101,"type":39},"2023-10-31",{"date":103,"type":20},"2030-12-31",{"name":45,"class":46},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"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":114,"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).",[26,90,28],"2025-07-29",{"date":119,"type":39},"2025-07-31",{"date":121,"type":39},"2022-06-21",{"date":123,"type":20},"2028-01-01",{"name":45,"class":46},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":47},"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":133,"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).",[26,90,28],[137,93,94,138],"dual chamber","AV Block","2025-04-03",{"date":141,"type":39},"2025-04-06",{"date":101,"type":39},{"date":144,"type":20},"2030-05",{"name":45,"class":46},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":47},"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":154,"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).",[26,157,28],"Arrhythmia","2025-04-02",{"date":160,"type":39},"2025-04-04",{"date":162,"type":39},"2024-01-18",{"date":164,"type":20},"2031-01",{"name":45,"class":46}]