[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657590":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":23,"studyPopulation":23,"armGroups":48,"interventions":59,"overallOfficials":23,"centralContacts":69,"locations":75,"responsibleParty":94,"collaborators":23,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":23,"enrollmentInfo":107,"targetDuration":23,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":23,"overallStatus":119,"whyStopped":23,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Universitatsklinikum Ruppin-Brandenburg GmbH","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Status","Hierarchical clinical composite score: 1. Patients who died for a cardiovascular cause, received a heart transplantation or had an unplanned emergency department visit or hospitalization for heart failure are 'unchanged\u002Fworsened'.\n\n2\\. Patients who receive a modification of the implanted CRTP system for reasons of presumed inefficacy of the randomized system are 'unchanged\u002Fworsened'.\n\n3\\. Patients to whom the above does not apply and who have \\>20% absolute increase in LVEF at 12 months or earlier are 'markedly improved', and patients who have \\\u003C5% absolute increase in LVEF at 12 months are 'unchanged\u002Fworsened' 4. Patients to whom the above does not apply the KCCQ-12 overall summary score will be assessed. Those who have ≥ 5 points increase in KCCQ-12 overall summary score are 'markedly improved', and patients who have ≥5 points decrease are 'unchanged\u002Fworsened'.\n\n5\\. Patients for whom none of the conditions above apply, are 'moderately improved'.","From enrollment to 12 month follow up",[14,18,21,24,26,28,31,33,36],{"measure":15,"description":16,"timeFrame":17},"Electrocardiographic characteristics","ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time.","enrollment to 12 month follow up",{"measure":19,"description":20,"timeFrame":17},"Echocardiographic characteristics","left ventricular ejection fraction (LVEF), left ventricular end-systolic\u002F end-diastolic volume (LVESV\u002FLVEDV), LV EDD, LV ESD.",{"measure":22,"description":23,"timeFrame":17},"NYHA class",null,{"measure":25,"description":23,"timeFrame":17},"NT-ProBNP",{"measure":27,"description":23,"timeFrame":17},"6 minutes walking test",{"measure":29,"description":30,"timeFrame":17},"Quality of Life Questionaire","KCCQ-12",{"measure":32,"description":23,"timeFrame":17},"Worsened heart failure",{"measure":34,"description":35,"timeFrame":17},"Arrhythmic events","VT\u002FVF\u002FAF occurrence",{"measure":37,"description":23,"timeFrame":17},"Mortality",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":23,"timePerspective":23,"maskingInfo":43},"RANDOMIZED","PARALLEL","All patienties will be implanted with LOT-CRT-P.","TREATMENT",{"masking":44,"maskingDescription":45,"whoMasked":46},"SINGLE","patients and implanting cardiologist will be blinded",[47],"PARTICIPANT",[49,54],{"label":50,"type":6,"description":51,"interventionNames":52},"LOT group","LOT group: Implanted with LOT-CRT-P device and programmed with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG.",[53],"Device: LOT-CRT-P (Programming: LOT-CRT-P)",{"label":55,"type":6,"description":56,"interventionNames":57},"NOT group (LBBAP)","NOT group: Implanted with LOT-CRT-P device and programmed with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms.",[58],"Device: LOT-CRT-P (Programming: LBBAP)",[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":23},"DEVICE","LOT-CRT-P (Programming: LBBAP)","All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead.\n\nDevice programming:\n\nNOT group: Synchronized with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms.\n\nAfter 12 months and study end, each patient receives a personalised and optimally tailored adjustment.",[55],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":23},"LOT-CRT-P (Programming: LOT-CRT-P)","Device: LOT-CRT-P (Programming: LOT-CRT-P) All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead.\n\nDevice programming:\n\nLOT group: Pacing with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG.\n\nAfter 12 months and study end, each patient receives a personalised and optimally tailored adjustment.",[50],[70],{"name":71,"role":72,"phone":73,"phoneExt":23,"email":74},"Guram PD Dr. Imnadze","CONTACT","+491733728489","g.imnadze@ukrb.de",[76],{"facility":77,"status":23,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"University Hospital Ruppin-Brandenburg","Neuruppin","Brandenburg","16816","Germany","DE",{"type":84,"coordinates":85},"Point",[86,87],12.80311,52.92815,{"lat":87,"lon":86},[90],{"name":91,"role":72,"phone":92,"phoneExt":23,"email":93},"Guram Imnadze, MD, PhD","+493391393111","imnadze@web.de",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","PD Dr. Guram Imnadze","Chief Physician of the Medical Clinic A- Rhythmology","100657590","a-comparison-of-left-bundle-branch-optimized-cardiac-resynchronization-therapy-vs-left-bundle-branch-area-pacing-alone-100657590",false,"NCT07842874","A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone","LOT or NOT","Inclusion Criteria:\n\nAge ≥ 18 years Clinical indication for CRTP implantation according to the current ESC guidelines De novo implantation LBBB (QRS duration ≥130 ms) NYHA II-IV\n\nExclusion Criteria:\n\nSevere mitral or aortic valvular disease History of VT\u002FVF Failed implantation of any component of the LOT-CRTP system\u002F incompleteness of the system to be implanted Pregnancy Life expectancy \\\u003C 1 year Inability to give written consent","ALL","18 Years",{"count":108,"type":109},124,"ESTIMATED","INTERVENTIONAL",[112],"NA","Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy and may offer advantages over conventional biventricular pacing (BVP), including improved clinical outcomes. However, its effectiveness may be limited in patients with distal conduction system disease, significant endocardial and\u002For myocardial damage, as well as when direct left bundle branch capture is not achieved. Conventional CRT remains an effective therapy but is associated with procedural challenges and a significant non-responder rate. Current guidelines support the use of LBBAP and BVP either individually or in combination as Left Bundle Branch Optimized CRT (LOT-CRT). Recent data suggest that LOT-CRT may provide superior electrical and hemodynamic resynchronization compared with both LBBAP and BVP. However, there is a lack of randomized trials comparing LBBAP and LOT-CRT in patients with CRT-P indication. The aim of this study is to compare the LOT-CRTP to LBBAP alone.",[115,116,117,118],"Heart Failure","Left Bundle Branch Area Pacing","Cardiac Resynchronization Therapy","Conduction System Pacing","NOT_YET_RECRUITING","2026-09-21",{"date":122,"type":123},"2026-09-25","ACTUAL",{"date":125,"type":109},"2027-02",{"date":127,"type":109},"2029-03",{"name":96,"class":6},1]