[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509241":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":63,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Azienda Ospedaliero Universitaria Maggiore della Carita","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Left bundle branch area pacing (LBBAP)","EXPERIMENTAL","Implant of the ventricular lead of the pacemaker in the left bundle branch area",[13],"Device: Left bundle branch area pacing (LBBAP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Right ventricular pacing (RVP)","ACTIVE_COMPARATOR","Implant of the ventricular lead of the pacemaker in a conventional site for pacing (apex\u002Fparaapical interventricular septum)",[19],"Device: Right ventricular pacing (RVP)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Pacing of the conduction system of the heart to obtain physiological activation",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Conventional ventricular pacing",[15],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Gabriele Dell'Era, MD","CONTACT","03213733294","+39","gabriele.dellera@maggioreosp.novara.it",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Chiara Ghiglieno, MD","chiara.ghiglieno@maggioreosp.novara.it",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital \"Maggiore della Carità\", Division of Cardiology","RECRUITING","Novara","28100","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],8.62118,45.44694,{"lat":51,"lon":50},[54,56,57,59,61],{"name":31,"role":32,"phone":55,"phoneExt":25,"email":35},"03213733590",{"name":37,"role":32,"phone":55,"phoneExt":25,"email":38},{"name":37,"role":58,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":60,"role":58,"phone":25,"phoneExt":25,"email":25},"Federica De Vecchi, MD",{"name":62,"role":58,"phone":25,"phoneExt":25,"email":25},"Matteo Santagostino, MD",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Gabriele Dell'Era","Chief of Electrophysiology Unit","100509241","left-bundle-brancharea-pacing-to-avoid-pacing-induced-cardiomyopathy-100509241",false,"NCT05910866","LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy","LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial","LEAP-CAR","Inclusion Criteria:\n\n* advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\\>45%)\n\nExclusion Criteria:\n\n* LVEF ≤45%\n* signs or symptoms of heart failure at enrollment\n* unstable angina or acute coronary syndrome \\\u003C3 months\n* percutaneous coronary intervention or coronary-artery bypass surgery \\\u003C3 months\n* life expectancy \\\u003C6 months\n* previous hospitalization for heart failure\n* evidence of pulmonary artery hypertension of any origin\n* valvular disease greater than moderate\n* previous heart transplant pregnancy","ALL","18 Years",{"count":78,"type":79},130,"ESTIMATED","INTERVENTIONAL",[82],"NA","LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \\>45%.\n\nLEAP-CAR is a randomized, prospective, double blind clinical trial.",[85,86,87,88,89],"Bradycardia","Heart Failure","Pacemaker-Induced Cardiomyopathy","Conduction Block, Atrioventricular","Cardiac Remodeling, Ventricular",[91,92,93,94],"left bundle branch area pacing","conduction system pacing","physiologic pacing","pacing-induced cardiomyopathy","2024-01-29",{"date":97,"type":98},"2024-01-30","ACTUAL",{"date":100,"type":98},"2023-06-10",{"date":102,"type":79},"2026-06-10",{"name":5,"class":6},1]