[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sinus-node-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sinus-node-disease":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},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.",[25,26],"Sinus Node Disease","Atrioventricular Block",[28,29,30,31],"Conduction system pacing","Closed loop stimulation","Dual-chamber pacemaker","Left bundle branch area pacing","RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-02","ACTUAL",{"date":33,"type":20},{"date":39,"type":20},"2030-05-29",{"name":41,"class":42},"Biotronik SE & Co. KG","INDUSTRY",12,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100467459","physiological-ventricular-pacing-vs-managed-ventricular-pacing-for-persistent-af-prevention-in-prolonged-av-interval-100467459","NCT05367037","Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval","Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT","PhysioVP-AF","Inclusion Criteria:\n\n18 years older patients, able to express Informed Consent, with prolonged atrioventricular interval (PR\\>180 ms) and one of the following indications for PM implantation according to current guidelines:\n\n* Sinus node disease.\n* Paroxysmal type1or 2 second-degree AV-block.\n\nExclusion Criteria:\n\n* Candidacy for implantable cardioverter-defibrillator or cardiac resynchronization therapy device implantation.\n* Severe grade mitral or aortic regurgitation\u002Fstenosis.\n* Atrial fibrillation ablation (left pulmonary veins).\n* Cardiac surgery \\\u003C 3 months before PM implantation.\n* History of long-standing persistent AF.\n* Permanent third-degree AV block.\n* Participation in another clinical trial in the past 3 months.\n* Pregnancy or intention to become pregnant.\n* Life expectancy of \\\u003C 3 years.",{"count":53,"type":20},640,"INTERVENTIONAL",[56],"NA","A multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation to evaluate the superiority of physiological ventricular pacing (proposed modality) vs. managed ventricular pacing (control) for prevention of persistent AF (PeAF) occurrence in patients with prolonged atrioventricular interval (PR≥180 ms) and indication for pacing: sinus node disease and\u002For paroxysmal type 1 or 2-second degree AV block.",[25,59],"Atrioventricular; Block, Second Degree (Types I and II)",[25,61,62,63],"Paroxysmal AV-block","conduction system pacing","persistent atrial fibrillation","2025-05-06",{"date":66,"type":36},"2025-05-11",{"date":68,"type":36},"2022-07-27",{"date":70,"type":20},"2028-12",{"name":72,"class":73},"Quovadis Associazione","OTHER",1]