[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623159":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":36,"armGroups":32,"interventions":37,"overallOfficials":32,"centralContacts":42,"locations":49,"responsibleParty":389,"collaborators":32,"id":391,"slug":392,"hasResults":393,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":32,"eligibilityCriteria":397,"healthyVolunteers":393,"sex":398,"minAge":399,"maxAge":32,"enrollmentInfo":400,"targetDuration":403,"studyType":404,"phases":32,"briefSummary":405,"conditions":406,"keywords":414,"overallStatus":175,"whyStopped":32,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},{"fullName":5,"class":6},"Biotronik SE & Co. KG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":32},[9,13,17,20,23,26,29],{"measure":10,"description":11,"timeFrame":12},"SADE-d free rate related to any investigatonal device","Rate of serious adverse device effects possible, probable or causal related to any investigational device.","throughout study duration, average of 4 years; annual evaluations",{"measure":14,"description":15,"timeFrame":16},"Rate of successful acute implantation in LBBAP using investigational devices in LBBAP","All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success.","Day 1",{"measure":18,"description":19,"timeFrame":16},"Capture type at implantation","The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters.",{"measure":21,"description":22,"timeFrame":12},"Long-term maintenance of LBBAP","The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.",{"measure":24,"description":25,"timeFrame":12},"Electrical parameters - pacing threshold","The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.",{"measure":27,"description":28,"timeFrame":12},"Electrical parameters - sensing amplitude","The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.",{"measure":30,"description":31,"timeFrame":12},"Electrical parameters - pacing impedance","The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"OTHER","PROSPECTIVE","The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.",[38],{"type":39,"name":40,"description":41,"armGroupLabels":32,"otherNames":32},"DEVICE","Implantation of the Solia CSP S pacing lead for LBBAP","Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Johannes 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Lévêque","Pessac",{"type":57,"coordinates":127},[128,129],-0.6324,44.80565,{"lat":129,"lon":128},{"facility":132,"status":52,"city":133,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":32},"Universitäts-Herzzentrum Freiburg Bad Krozingen","Bad Krozingen","Germany","DE",{"type":57,"coordinates":137},[138,139],7.7,47.91667,{"lat":139,"lon":138},{"facility":142,"status":52,"city":143,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":144,"geoPoint":148,"contacts":32},"Kerckhoff-Klinik GmbH","Bad Nauheim",{"type":57,"coordinates":145},[146,147],8.73859,50.36463,{"lat":147,"lon":146},{"facility":150,"status":52,"city":151,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":152,"geoPoint":156,"contacts":32},"Herz- und Diabeteszentrum NRW","Bad Oeynhausen",{"type":57,"coordinates":153},[154,155],8.80365,52.20699,{"lat":155,"lon":154},{"facility":158,"status":52,"city":159,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":160,"geoPoint":164,"contacts":32},"Krankenhaus Porz am Rhein gGmbH","Cologne",{"type":57,"coordinates":161},[162,163],6.95,50.93333,{"lat":163,"lon":162},{"facility":166,"status":52,"city":167,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":168,"geoPoint":172,"contacts":32},"Niels-Stensen-Kliniken, Marienhospital Osnabrück","Osnabrück",{"type":57,"coordinates":169},[170,171],8.0498,52.27264,{"lat":171,"lon":170},{"facility":174,"status":175,"city":176,"state":32,"zip":32,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":32},"Central Hospital of Northern Pest - Military Hospital","RECRUITING","Budapest","Hungary","HU",{"type":57,"coordinates":180},[181,182],19.04045,47.49835,{"lat":182,"lon":181},{"facility":185,"status":52,"city":176,"state":32,"zip":32,"country":177,"countryCode":178,"cosmosGeoPoint":186,"geoPoint":188,"contacts":32},"Semmelweis University",{"type":57,"coordinates":187},[181,182],{"lat":182,"lon":181},{"facility":190,"status":175,"city":191,"state":32,"zip":32,"country":177,"countryCode":178,"cosmosGeoPoint":192,"geoPoint":196,"contacts":32},"University of Pécs","Pécs",{"type":57,"coordinates":193},[194,195],18.22814,46.07617,{"lat":195,"lon":194},{"facility":198,"status":52,"city":199,"state":32,"zip":32,"country":177,"countryCode":178,"cosmosGeoPoint":200,"geoPoint":204,"contacts":32},"University of Szeged","Szeged",{"type":57,"coordinates":201},[202,203],20.14824,46.253,{"lat":203,"lon":202},{"facility":206,"status":52,"city":207,"state":32,"zip":32,"country":208,"countryCode":209,"cosmosGeoPoint":210,"geoPoint":214,"contacts":32},"Assuta Medical Center","Ashdod","Israel","IL",{"type":57,"coordinates":211},[212,213],34.64966,31.79213,{"lat":213,"lon":212},{"facility":216,"status":52,"city":217,"state":32,"zip":32,"country":208,"countryCode":209,"cosmosGeoPoint":218,"geoPoint":222,"contacts":32},"Soroka Medical Center","Beersheba",{"type":57,"coordinates":219},[220,221],34.7913,31.25181,{"lat":221,"lon":220},{"facility":224,"status":52,"city":225,"state":32,"zip":32,"country":208,"countryCode":209,"cosmosGeoPoint":226,"geoPoint":230,"contacts":32},"Hillel Yaffe Medical 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Perrino","Brindisi","Italy","IT",{"type":57,"coordinates":253},[254,255],17.93607,40.63215,{"lat":255,"lon":254},{"facility":258,"status":52,"city":259,"state":32,"zip":32,"country":250,"countryCode":251,"cosmosGeoPoint":260,"geoPoint":264,"contacts":32},"Niguarda Hospital","Milan",{"type":57,"coordinates":261},[262,263],12.59836,42.78235,{"lat":263,"lon":262},{"facility":266,"status":175,"city":267,"state":32,"zip":32,"country":250,"countryCode":251,"cosmosGeoPoint":268,"geoPoint":272,"contacts":32},"A.O.U. Maggiore della Carita di Novara","Novara",{"type":57,"coordinates":269},[270,271],8.62118,45.44694,{"lat":271,"lon":270},{"facility":274,"status":52,"city":275,"state":32,"zip":32,"country":250,"countryCode":251,"cosmosGeoPoint":276,"geoPoint":280,"contacts":32},"Ospedale di Piove di Sacco","Piove di Sacco",{"type":57,"coordinates":277},[278,279],12.03683,45.29665,{"lat":279,"lon":278},{"facility":282,"status":52,"city":283,"state":32,"zip":32,"country":250,"countryCode":251,"cosmosGeoPoint":284,"geoPoint":288,"contacts":32},"Fondazione Policlinico Universitario \"Agostino Gemelli\" Università Cattolica del Sacro Cuore","Roma",{"type":57,"coordinates":285},[286,287],11.10642,44.99364,{"lat":287,"lon":286},{"facility":290,"status":52,"city":291,"state":32,"zip":32,"country":250,"countryCode":251,"cosmosGeoPoint":292,"geoPoint":296,"contacts":32},"SS Annunziata Taranto","Taranto",{"type":57,"coordinates":293},[294,295],17.24707,40.46438,{"lat":295,"lon":294},{"facility":298,"status":52,"city":299,"state":32,"zip":32,"country":300,"countryCode":301,"cosmosGeoPoint":302,"geoPoint":306,"contacts":32},"Pauls Stradins Clinical University Hospital","Riga","Latvia","LV",{"type":57,"coordinates":303},[304,305],24.10589,56.946,{"lat":305,"lon":304},{"facility":308,"status":52,"city":309,"state":32,"zip":32,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":32},"Auckland City Hospital","Grafton","New Zealand","NZ",{"type":57,"coordinates":313},[314,315],174.76566,-36.86029,{"lat":315,"lon":314},{"facility":318,"status":52,"city":319,"state":32,"zip":32,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":32},"Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra","Coimbra","Portugal","PT",{"type":57,"coordinates":323},[324,325],-8.41996,40.20686,{"lat":325,"lon":324},{"facility":328,"status":52,"city":329,"state":32,"zip":32,"country":320,"countryCode":321,"cosmosGeoPoint":330,"geoPoint":334,"contacts":32},"Unidade Local de Saúde de Santa Maria, E. P. E.","Lisbon",{"type":57,"coordinates":331},[332,333],-9.1498,38.72509,{"lat":333,"lon":332},{"facility":336,"status":52,"city":329,"state":32,"zip":32,"country":320,"countryCode":321,"cosmosGeoPoint":337,"geoPoint":339,"contacts":32},"Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta",{"type":57,"coordinates":338},[332,333],{"lat":333,"lon":332},{"facility":341,"status":52,"city":342,"state":32,"zip":32,"country":343,"countryCode":344,"cosmosGeoPoint":345,"geoPoint":349,"contacts":32},"Hospital Universitari Germans Trias i Pujol","Barcelona","Spain","ES",{"type":57,"coordinates":346},[347,348],2.15899,41.38879,{"lat":348,"lon":347},{"facility":351,"status":52,"city":352,"state":32,"zip":32,"country":343,"countryCode":344,"cosmosGeoPoint":353,"geoPoint":357,"contacts":32},"Hospital La Luz","Madrid",{"type":57,"coordinates":354},[355,356],-3.70256,40.4165,{"lat":356,"lon":355},{"facility":359,"status":52,"city":360,"state":32,"zip":32,"country":343,"countryCode":344,"cosmosGeoPoint":361,"geoPoint":365,"contacts":32},"Hospital Universitario 12 de Octubre","Valencia",{"type":57,"coordinates":362},[363,364],-0.37966,39.47391,{"lat":364,"lon":363},{"facility":367,"status":52,"city":360,"state":32,"zip":32,"country":343,"countryCode":344,"cosmosGeoPoint":368,"geoPoint":370,"contacts":32},"Hospital Universitario La Fe",{"type":57,"coordinates":369},[363,364],{"lat":364,"lon":363},{"facility":372,"status":52,"city":373,"state":32,"zip":32,"country":374,"countryCode":375,"cosmosGeoPoint":376,"geoPoint":380,"contacts":32},"Inselspital, Universitätsspital Bern","Bern","Switzerland","CH",{"type":57,"coordinates":377},[378,379],7.44744,46.94809,{"lat":379,"lon":378},{"facility":382,"status":52,"city":383,"state":32,"zip":32,"country":374,"countryCode":375,"cosmosGeoPoint":384,"geoPoint":388,"contacts":32},"Universitätsspital Zürich (USZ)","Zurich",{"type":57,"coordinates":385},[386,387],8.55,47.36667,{"lat":387,"lon":386},{"type":390,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100623159","biostreamcsp-study-100623159",false,"NCT07393009","BIO|STREAM.CSP Study","Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)","Inclusion Criteria:\n\n* Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P\u002F-D)\n* Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO\\|MASTER.CSP study\n* Ability to understand the nature of the study\n* Ability and willingness to perform all follow-up visits\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept\n\nExclusion Criteria:\n\n* Planned dation from intended use\n* Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment\n* Life-expectancy less than 12 months\n* Pregnant or breast feeding\n* Age less than 18 years\n* Participation in an interventional clinical investigation, except for submodules within this study.","ALL","18 Years",{"count":401,"type":402},1000,"ESTIMATED","4 Years","OBSERVATIONAL","The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.",[407,408,409,410,411,412,413],"Cardiac Pacing","Cardiac Pacemaker","Implantable Cardioverter Defibrillator","Cardiac Resynchronization Therapy Devices","Bradycardia","Tachycardia","Heart Failure",[415,416],"Conduction system pacing (CSP)","Left bundle branch area pacing (LBBAP)","2026-06-24",{"date":419,"type":420},"2026-06-29","ACTUAL",{"date":422,"type":420},"2026-05-25",{"date":424,"type":402},"2033-02-01",{"name":5,"class":6},40]