[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053262":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":21,"centralContacts":40,"locations":21,"responsibleParty":46,"collaborators":21,"id":48,"slug":21,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":21,"enrollmentInfo":56,"targetDuration":21,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":21,"overallStatus":66,"whyStopped":21,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":21},{"fullName":5,"class":6},"Medtronic Cardiac Rhythm and Heart Failure","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1","EXPERIMENTAL","LBBAP therapy for 6 months followed by LOT-CRT for 6 months",[13,14],"Device: LBBAP Therapy","Device: LOT-CRT",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence 2","LOT-CRT for 6 months followed by LBBAP therapy for 6 months",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Observational Treatment Arm",null,[23,14],"Device: ICD",[25,30,34,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":21},"DEVICE","LBBAP Therapy","CRT-D programmed for LBBAP (LV lead OFF)",[9,16],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":21},"LOT-CRT","CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)",[9,16],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":21},"ICD","ICD programmed for LBBAP",[20],{"type":26,"name":31,"description":32,"armGroupLabels":39,"otherNames":21},[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":21,"email":45},"D'Anne Kudlik","CONTACT","763-526-1843","danne.e.kudlik@medtronic.com",{"type":47,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100053262",false,"NCT07526896","Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing","ACHIEVED LBBAP","Inclusion Criteria:\n\n* Subject meets current ACC\u002FAHA\u002FHRS guidelines for implantation of a CRT-D device.\n* Subject has documented LVEF ≤ 35% within 60 days of enrollment.\n* Subject meets the criteria for presence of Strauss-defined LBBB.\n* Subject meets NYHA classification II or III.\n* Subject is willing and able to provide written consent.\n* Subject is at least 18 years of age at the time of consent.\n* Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.\n* The subject's medical records must be accessible by the enrolling site over the follow-up period.\n\nExclusion Criteria:\n\n* Subject has documented myocardial infarction before enrollment.\n* Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.\n* Subject has 2nd or 3rd degree AV block.\n* Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).\n* Subject has intrinsic (non-paced) QRS duration ≤ 120ms.\n* Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.\n* Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).\n* Subject underwent valve surgery within 90 days prior to enrollment.\n* Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.\n* Subject is post-heart transplantation or is actively listed on the transplantation list.\n* Subject is implanted with a left ventricular assist device (LVAD).\n* Subject has severe renal disease.\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.\n* Subject has complex and uncorrected congenital heart disease.\n* Subject has life expectancy of less than 12 months.\n* Subject is pregnant or breastfeeding.\n* Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.","ALL","18 Years",{"count":57,"type":58},110,"ESTIMATED","INTERVENTIONAL",[61],"NA","This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis",[64,65],"Heart Failure","Systolic Bundle Branch Block, Left","NOT_YET_RECRUITING","2026-07-09",{"date":69,"type":70},"2026-07-13","ACTUAL",{"date":72,"type":58},"2026-08",{"date":74,"type":58},"2029-09",{"name":5,"class":6}]