[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637969":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":22,"responsibleParty":182,"collaborators":7,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":7,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":192,"enrollmentInfo":193,"targetDuration":196,"studyType":197,"phases":7,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":92,"whyStopped":7,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Biotronik SE & Co. KG","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Left bundle branch area pacing with Closed Loop Stimulation","Permanent dual-chamber cardiac pacing with ventricular lead placement in the left bundle branch area and activation of the Closed Loop Stimulation (CLS) rate-responsive algorithm.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Martina Del Maestro","CONTACT","+393426529214","CLS-CSP-STREAM@biotronik.com",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":18},"Paola Napoli","+393357369277",[23,38,52,64,78,90,104,116,128,141,156,170],{"facility":24,"status":25,"city":26,"state":7,"zip":7,"country":27,"countryCode":7,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Masarykova nemocnice v Usti nad Labem","NOT_YET_RECRUITING","Ústí nad Labem","Czechia",{"type":29,"coordinates":30},"Point",[31,32],14.03227,50.6607,{"lat":32,"lon":31},[35],{"name":36,"role":16,"phone":7,"phoneExt":7,"email":37},"Jíří Holý","jiri.holy@kzcr.eu",{"facility":39,"status":25,"city":40,"state":7,"zip":7,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Semmelweis University","Budapest","Hungary","HU",{"type":29,"coordinates":44},[45,46],19.04045,47.49835,{"lat":46,"lon":45},[49],{"name":50,"role":16,"phone":7,"phoneExt":7,"email":51},"László Gellér","geller.laszlo@kardio.sote.hu",{"facility":53,"status":25,"city":54,"state":7,"zip":7,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"University of Szeged","Szeged",{"type":29,"coordinates":56},[57,58],20.14824,46.253,{"lat":58,"lon":57},[61],{"name":62,"role":16,"phone":7,"phoneExt":7,"email":63},"Tamás Szili-Török","szili-torok.tamas@u-szeged.hu",{"facility":65,"status":25,"city":66,"state":7,"zip":7,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Ospedale Di Summa - Perrino","Brindisi","Italy","IT",{"type":29,"coordinates":70},[71,72],17.93607,40.63215,{"lat":72,"lon":71},[75],{"name":76,"role":16,"phone":7,"phoneExt":7,"email":77},"Ennio CL Pisanò","enniopisano@hotmail.com",{"facility":79,"status":25,"city":80,"state":7,"zip":7,"country":67,"countryCode":68,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Niguarda hospital","Milan",{"type":29,"coordinates":82},[83,84],12.59836,42.78235,{"lat":84,"lon":83},[87],{"name":88,"role":16,"phone":7,"phoneExt":7,"email":89},"Matteo Baroni","bimatteo@gmail.com",{"facility":91,"status":92,"city":93,"state":7,"zip":7,"country":67,"countryCode":68,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"A.O.U. Maggiore della Carita di Novara","RECRUITING","Novara",{"type":29,"coordinates":95},[96,97],8.62118,45.44694,{"lat":97,"lon":96},[100],{"name":101,"role":16,"phone":102,"phoneExt":7,"email":103},"Gabriele Dell'Era","+3903213731","gdellera@gmail.com",{"facility":105,"status":25,"city":106,"state":7,"zip":7,"country":67,"countryCode":68,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Ospedale di Piove di Sacco","Piove di Sacco",{"type":29,"coordinates":108},[109,110],12.03683,45.29665,{"lat":110,"lon":109},[113],{"name":114,"role":16,"phone":7,"phoneExt":7,"email":115},"Leonardo Marinaccio","leonardo.marinaccio@aulss6.veneto.it",{"facility":117,"status":25,"city":118,"state":7,"zip":7,"country":67,"countryCode":68,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Fondazione Policlinico Universitario \"Agostino Gemelli\" Università Cattolica del Sacro Cuore","Roma",{"type":29,"coordinates":120},[121,122],11.10642,44.99364,{"lat":122,"lon":121},[125],{"name":126,"role":16,"phone":7,"phoneExt":7,"email":127},"Maria Lucia Narducci","marialucia.narducci@policlinicogemelli.it",{"facility":129,"status":25,"city":130,"state":7,"zip":7,"country":67,"countryCode":68,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"SS Annunziata Taranto","Taranto",{"type":29,"coordinates":132},[133,134],17.24707,40.46438,{"lat":134,"lon":133},[137],{"name":138,"role":16,"phone":139,"phoneExt":7,"email":140},"Cosimo Mandurino","+390994585111","mandurinocosimo@gmail.com",{"facility":142,"status":25,"city":143,"state":7,"zip":7,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra","Coimbra","Portugal","PT",{"type":29,"coordinates":147},[148,149],-8.41996,40.20686,{"lat":149,"lon":148},[152,154],{"name":7,"role":16,"phone":7,"phoneExt":7,"email":153},"joaoaferreira29@gmail.com",{"name":155,"role":16,"phone":7,"phoneExt":7,"email":7},"João Ferreira",{"facility":157,"status":25,"city":158,"state":7,"zip":7,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Hospital Universitario 12 de Octubre","Madrid","Spain","ES",{"type":29,"coordinates":162},[163,164],-3.70256,40.4165,{"lat":164,"lon":163},[167],{"name":168,"role":16,"phone":7,"phoneExt":7,"email":169},"Alvaro Marco del Castillo","amarco89@hotmail.com",{"facility":171,"status":25,"city":172,"state":7,"zip":7,"country":159,"countryCode":160,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Hospital Universitario La Fe","Valencia",{"type":29,"coordinates":174},[175,176],-0.37966,39.47391,{"lat":176,"lon":175},[179],{"name":180,"role":16,"phone":7,"phoneExt":7,"email":181},"Óscar Cano Pérez","cano_osc@gva.es",{"type":183,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100637969","biostreamcsp-cls-100637969",false,"NCT07608822","BIO|STREAM.CSP CLS","Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP) With Focus on Closed Loop Stimulation (CLS)","Inclusion Criteria:\n\n* Enrolled in the BIO\\|STREAM.CSP registry\n* Standard indication for dual-chamber pacing due to any form of sinus node disease according to guidelines\n* DDD-CLS pacing mode activated\n* Either ≥ II degree AV block, or native PR interval ≥ 200 ms at baseline ECG with expected RVP ≥ 20%\n\nExclusion Criteria:\n\n* Implantation dates back more than 90 days\n* History of clinical AF\n* Patients intended to receive, or already received a pacing lead for traditional RV pacing, His bundle pacing or right bundle branch pacing\n* Upgrade from previous pacemaker system\n* Patients transitioning from the BIO\\|MASTER.CSP study\n* DDAF episodes present in the device memory at the time of registration","ALL","18 Years",{"count":194,"type":195},150,"ESTIMATED","24 Months","OBSERVATIONAL","This clinical study is a prospective, observational submodule of the BIO\\|STREAM.CSP registry designed to evaluate clinical outcomes in patients receiving BIOTRONIK dual-chamber pacemakers that combine conduction system pacing-specifically left bundle branch area pacing (LBBAP)-with Closed Loop Stimulation (CLS). The purpose of the study is to better understand how this combined pacing strategy performs in routine clinical practice and whether it may help reduce the occurrence of atrial fibrillation in patients with sinus node dysfunction (SND) and concomitant atrioventricular (AV) conduction disorders.\n\nThe primary question the study seeks to answer is what the incidence of device-detected atrial fibrillation (DDAF) is over a 24-month follow-up period in patients treated with LBBAP and active CLS. Additionally, the study explores how CLS dynamically modulates pacing rates when the ventricular lead is positioned within the conduction system, and whether this physiological pacing approach may mitigate the negative effects associated with conventional right ventricular pacing.\n\nOverall, this study aims to generate real-world evidence to support optimization of pacemaker programming and to inform clinical decision-making regarding the use of CLS in combination with conduction system pacing, with the goal of improving patient outcomes and reducing atrial arrhythmia burden.",[200,201],"Sinus Node Disease","Atrioventricular Block",[203,204,205,206],"Conduction system pacing","Closed loop stimulation","Dual-chamber pacemaker","Left bundle branch area pacing","2026-05-29",{"date":209,"type":210},"2026-06-02","ACTUAL",{"date":207,"type":195},{"date":213,"type":195},"2030-05-29",{"name":5,"class":6},12]