[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552571":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":109,"collaborators":111,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":25,"enrollmentInfo":125,"targetDuration":25,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":25,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Bellvitge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"deep","EXPERIMENTAL","The ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration \\\u003C=140ms.",[13],"Device: Pacemaker implant",{"label":15,"type":16,"description":17,"interventionNames":18},"Apex","ACTIVE_COMPARATOR","The ventricular lead will be placed in the right ventricular apex.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Pacemaker implant","All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Andrea Di Marco, MD, PhD","IDIBELL and Hospital Universitario de Bellvitge","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","+34932 60 75 00","8385","adimarco@bellvitgehospital.cat",[38,53,64,75,87,98],{"facility":39,"status":40,"city":41,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital Vall d'Hebrón","NOT_YET_RECRUITING","Barcelona","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],2.15899,41.38879,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":25,"phoneExt":25,"email":25},"Raquel Adeliño Recasens",{"facility":54,"status":40,"city":55,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Hospital General Universitario de Castellón","Castellon",{"type":45,"coordinates":57},[58,59],-0.04935,39.98567,{"lat":59,"lon":58},[62],{"name":63,"role":33,"phone":25,"phoneExt":25,"email":25},"Clara Gunturiz Beltrán",{"facility":65,"status":40,"city":66,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hospital Virgen de las Nieves","Granada",{"type":45,"coordinates":68},[69,70],-3.60667,37.18817,{"lat":70,"lon":69},[73],{"name":74,"role":33,"phone":25,"phoneExt":25,"email":25},"Manuel Molina Lerma",{"facility":76,"status":77,"city":78,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Hospital Universitario de Bellvitge","RECRUITING","L'Hospitalet de Llobregat",{"type":45,"coordinates":80},[81,82],2.10028,41.35967,{"lat":82,"lon":81},[85],{"name":86,"role":33,"phone":25,"phoneExt":25,"email":36},"Andrea Di Marco",{"facility":88,"status":40,"city":89,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Hospital La Fe","Valencia",{"type":45,"coordinates":91},[92,93],-0.37966,39.47391,{"lat":93,"lon":92},[96],{"name":97,"role":33,"phone":25,"phoneExt":25,"email":25},"Oscar Cano Perez",{"facility":99,"status":40,"city":100,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hospital Lozano Blesa","Zaragoza",{"type":45,"coordinates":102},[103,104],-0.87734,41.65606,{"lat":104,"lon":103},[107],{"name":108,"role":33,"phone":25,"phoneExt":25,"email":25},"Javier Ramos Maqueda",{"type":30,"investigatorFullName":86,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator",[112,114],{"name":113,"class":6},"Fundació La Marató de TV3",{"name":115,"class":6},"Hospital Universitari de Bellvitge","100552571","left-septal-or-deep-septal-pacing-to-prevent-pacing-induced-cardiomyopathy-100552571",false,"NCT06474819","Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy","DEEP","Inclusion Criteria:\n\n* First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (\\\u003C45lpm).\n* LVEF\\>50% at echocardiography performed maximum 7 days before pacemaker implant.\n* Informed consent signature.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C12 months\n* Severe cardiac valvular abnormality requiring intervention\n* Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.\n* Inclusion in another trial which may influence the results of this study.","ALL","18 Years",{"count":126,"type":127},326,"ESTIMATED","INTERVENTIONAL",[130],"NA","Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \\>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.\n\nPatients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.",[133,134],"Complete Heart Block","Second Degree Atrioventricular Block Möbitz Type II","2024-07-12",{"date":137,"type":138},"2024-07-15","ACTUAL",{"date":135,"type":138},{"date":141,"type":127},"2027-01-12",{"name":5,"class":6},6]