[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biotronik SE & Co. KG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,75,97,126,148],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":19,"type":20},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.",[25,26,27,28,29,30,31],"Cardiac Pacing","Cardiac Pacemaker","Implantable Cardioverter Defibrillator","Cardiac Resynchronization Therapy Devices","Bradycardia","Tachycardia","Heart Failure",[33,34],"Conduction system pacing (CSP)","Left bundle branch area pacing (LBBAP)","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2026-05-25",{"date":43,"type":20},"2033-02-01",{"name":45,"class":46},"Biotronik SE & Co. KG","INDUSTRY",40,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":17,"enrollmentInfo":55,"targetDuration":57,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100637969","biostreamcsp-cls-100637969","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",{"count":56,"type":20},150,"24 Months","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.",[60,61],"Sinus Node Disease","Atrioventricular Block",[63,64,65,66],"Conduction system pacing","Closed loop stimulation","Dual-chamber pacemaker","Left bundle branch area pacing","2026-05-29",{"date":69,"type":39},"2026-06-02",{"date":67,"type":20},{"date":72,"type":20},"2030-05-29",{"name":45,"class":46},12,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100620633","biomastercorsky-family-post-market-study-for-the-corsky-family-of-icds-100620633","NCT07360158","BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs","Post-market Study for the CorSky Family of ICDs","Inclusion Criteria:\n\n* Standard indication for ICD or CRT-D therapy according to clinical guidelines\n* Planned for de novo implantation of an ICD\u002FCRT-D, or upgrade\u002Fexchange from existing ICD\u002FCRT-D or pacemaker\n* Ability to understand the nature of the study.\n* Ability and willingness to perform all on-site follow-up visits at the study site.\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept.\n\nExclusion Criteria:\n\n* For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia\n* For VR-T DX and CRT-DX: Patients requiring atrial pacing\n* Planned for His-Bundle-Pacing\n* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months\n* Pregnant or breast feeding.\n* Age less than 18 years.\n* Participation in an interventional clinical investigation in parallel to this study. ,\n* Life-expectancy less than 12 months.","99 Years",{"count":84,"type":20},151,"The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor\u002FRivacor family and inherit all iShock\u002FiShock\\_BC (Ilivia Neo, Intica Neo) implant and programmer software features.\n\nThe new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky).\n\nThe goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.",[87,31],"Tachyarrhythmia","NOT_YET_RECRUITING","2026-03-05",{"date":91,"type":39},"2026-03-06",{"date":93,"type":20},"2026-06",{"date":95,"type":20},"2028-05",{"name":45,"class":46},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":107,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100368267","observation-of-clinical-routine-care-for-patients-with-biotronik-implantable-cardiac-monitors-icms-100368267","NCT04075084","Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)","BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)","BIOSTREAM-ICM","Inclusion Criteria:\n\n* Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)\n* Patient is able to understand the nature of the registry and to provide written informed consent.\n* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.\n\nExclusion Criteria:\n\n* Patient is pregnant or breast feeding.\n* Patient is less than 18 years old.\n* Patient is participating in another interventional clinical investigation other than the submodules of BIO\\|STREAM.ICM",{"count":106,"type":20},1400,"3 Years","This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.",[30,110,111,29,112],"Atrial Fibrillation","Syncope","Cryptogenic Stroke",[114,115,116],"Implantable Cardiac Monitor","BIOMONITOR III","BIOMONITOR IV","2025-09-26",{"date":119,"type":39},"2025-10-01",{"date":121,"type":39},"2019-10-28",{"date":123,"type":20},"2027-08-30",{"name":45,"class":46},31,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":22,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100482355","post-market-clinical-follow-up-data-collection-from-procedures-with-biotronik-ep-products-100482355","NCT05560958","Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products","BIO|COLLECT-EP","Inclusion Criteria:\n\n* Indication for diagnostic or therapeutic EP intervention\n* EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories:\n\n  * BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)\n  * BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)\n  * BIOTRONIK transseptal sheath (Senovo Bi-Flex)\n* BIOTRONIK EP product is planned to be used within its intended purpose\n* Ability to understand the nature of the study\n* Willingness to provide written informed consent\n* Ability and willingness to perform all follow-up visits at the study site\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant or breastfeeding\n* Prior participation in this study with performed EP procedure\n* Participation in an interventional clinical investigation in parallel to the BIO\\|COLLECT.EP study",{"count":134,"type":20},280,"6 Months","This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.",[138],"Cardiac Arrhythmia","2025-09-16",{"date":141,"type":39},"2025-09-17",{"date":143,"type":39},"2023-01-16",{"date":145,"type":20},"2030-07",{"name":45,"class":46},1,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100592142","bioconceptbiomonitor-hf-collect-clinical-data-from-heart-failure-patients-using-biomonitor-devices-with-a-study-specific-research-software-100592142","NCT06989580","BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software","Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR","Inclusion Criteria:\n\n* Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment)\n* At least ONE of the following:\n\nAt least one documented admission with a primary diagnosis of worsening heart failure within last 12 months prior to enrollment;\n\nOR Unscheduled outpatient visit with increase of oral loop diuretics (more than 2-fold) or IV diuretic or ultrafiltration therapy for acute WHF within last 6 months prior to enrollment;\n\nOR elevated NT-proBNP\u002FBNP values within last 3 months prior to enrollment i.e.:\n\nIf LVEF \\>50% --\\> Patients in SR: \\>450 \u002F \\>150 pg\u002Fml; Patients with AF present: \\>900 \u002F \\>300 pg\u002Fml\n\nIf LVEF \\\u003C50% --\\> Patients in SR: \\>900 \u002F \\>300 pg\u002Fml; Patients with AF present: \\>1800 \u002F \\>450 pg\u002Fml\n\n* Ability to understand the nature of the study\n* Willingness to provide written informed consent\n* Ability and willingness to perform follow-up visits at the study site and via phone\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept\n\nExclusion Criteria:\n\n* Implanted with pacemaker, ICD or CRT device or ICM\n* Class I indication for a pacemaker, ICD or CRT according to current guidelines.\n* Permanent or long-standing persistent AF\n* Stroke, MI or PCI\u002FCABG within 3 months prior to enrollment\n* Patient is on chronic renal or peritoneal dialysis\n* Patient has complex adult congenital heart disease\n* Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy\n* Patient life expectancy is less than 1 year\n* Age \\\u003C18 years\n* Patient is participating in any other device or drug trial that may interfere with the treatment or protocol of this study or may significantly affect the study outcomes",{"count":156,"type":20},300,"INTERVENTIONAL",[159],"NA","\\[Plain language\\]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death rates. Most of what we know about arrhythmias in HF comes from patients with devices like ICDs or CRTs, which help manage heart rhythms. However, this study focuses on HF patients who don't qualify for these devices.\n\nResearchers use the BIOMONITOR IV, a device that tracks heart activity remotely over a long period. The goal is to understand how often arrhythmias occur in these patients and to develop a predictive algorithm for worsening HF (WHF). This algorithm could help doctors intervene early and improve treatment, reducing hospital visits and deaths related to WHF.\n\nTo make the BIOMONITOR IV more effective for HF management, its firmware is updated to collect additional data, such as fluid levels, breathing rate, and body position. These factors may be important for predicting WHF events.",[31,162,163,110],"Arrhythmia","Decompensated Heart Failure",[165],"Worsening Heart Failure (WHF)","2025-09-05",{"date":168,"type":39},"2025-09-08",{"date":170,"type":39},"2025-08-22",{"date":172,"type":20},"2028-12-31",{"name":45,"class":46},2,""]