[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633454":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":38,"slug":25,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":25,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":25,"overallStatus":56,"whyStopped":25,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":25},{"fullName":5,"class":6},"Medtronic Cardiac Rhythm and Heart Failure","INDUSTRY",[8,15],{"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],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","LBBAP Therapy","CRT-D programmed for LBBAP (LV lead OFF)",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"LOT-CRT","CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"D'Anne Kudlik","CONTACT","763-526-1843","danne.e.kudlik@medtronic.com",{"type":37,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100633454",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":47,"type":48},80,"ESTIMATED","INTERVENTIONAL",[51],"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).",[54,55],"Heart Failure","Systolic Bundle Branch Block, Left","NOT_YET_RECRUITING","2026-04-23",{"date":59,"type":60},"2026-04-28","ACTUAL",{"date":62,"type":48},"2026-08",{"date":64,"type":48},"2029-09",{"name":5,"class":6}]