[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bundle-branch-block\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bundle-branch-block":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100609076","safety-performance-and-clinical-benefit-of-pacing-the-left-bundle-branch-area---post-market-clinical-follow-up-100609076",false,"NCT07209852","Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up","Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF)","SEPTA PMCF","Inclusion Criteria:\n\n1. Subjects intended to undergo initial (de novo) pacing system implant using the INGEVITY+ lead in the left bundle branch area (LBBA) and a Boston Scientific single or dual- chamber pacemaker (Note: no prior attempted pacing system components);\n2. Subjects who are indicated for and will receive a Boston Scientific pacemaker system (including the single or dual chamber pacemaker and an INGEVITY+ lead in the LBBA location) for one of the following medical conditions:\n\n   1. Symptomatic paroxysmal or permanent second- or third-degree AV block,\n   2. Symptomatic bilateral bundle branch block,\n   3. Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \\[SA\\] block),\n   4. Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias,\n   5. Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes,\n   6. Adaptive-rate pacing for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and\u002For level of physical activity.\n\n      Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following:\n   7. Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block,\n   8. VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm,\n   9. Low cardiac output or congestive heart failure secondary to bradycardia;\n3. Subjects willing and capable of providing informed consent and participating in all testing and clinic visits associated with the clinical study at an approved clinical study location and at the intervals defined by protocol;\n4. Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;\n2. Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);\n3. Subjects with a Mechanical Tricuspid Valve;\n4. Subjects requiring hemodialysis or peritoneal dialysis;\n5. Subject has or has had implanted any pacemaker, ICD system, including subcutaneous, transvenous or leadless systems (Note: except for temporary pacing wire at time of enrollment) or CRT system;\n6. Subjects currently on an active organ transplant list;\n7. Subject referred to or admitted for hospice care;\n8. Subjects with a documented life expectancy of less than 12 months;\n9. Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor);\n10. Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment;\n11. Subjects who are unable or unwilling to comply with the follow-up schedule, including those living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome.","ALL","18 Years",{"count":20,"type":21},140,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.",[26,27,28,29],"Bradycardia","Atrioventricular Block","Sinus Node Dysfunction","Bundle-Branch Block",[31,32,33,34,35,36,37],"Left Bundle Branch Area Pacing (LBBAP)","INGEVITY+ Lead","Pacemaker","Cardiac Pacing","Conduction System Pacing","Ventricular Synchrony","Post-Market Clinical Follow-up","RECRUITING","2026-06-03",{"date":41,"type":42},"2026-06-04","ACTUAL",{"date":44,"type":42},"2025-12-19",{"date":46,"type":21},"2029-08-31",{"name":48,"class":49},"Boston Scientific Corporation","INDUSTRY",13,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":86,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100541040","contemporary-cardiac-stimulation-in-clinical-practice-left-biventricular-right-and-conduction-system-pacing-100541040","NCT06324682","ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing","Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing","TREEBEARD","Inclusion Criteria:\n\n* Indication for cardiac stimulation\n* Having performed the implantation of a device for cardiac stimulation\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Pregnancy status;",{"count":60,"type":21},8400,"The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.\n\nParticipants \\[patients over 18 years old with an indication to receive a definitive pacemaker\u002Fintracardiac defibrillator implant\\] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.",[63,27,64,65,66,67,68,69,70,71,72,73,74,75,29,76,77,78,79,80,81,82,83,84,85],"Arrhythmias, Cardiac","Reduced Systolic Function","Atrial Fibrillation","Bradyarrhythmia","Ventricular Tachycardia","Ventricular Dysfunction","Ventricular Fibrillation","Ventricular Arrythmia","Atrioventricular Nodal Disease","Atrioventricular Conduction Defects","Atrioventricular Block Complete","Atrioventricular Block Incomplete","Atrioventricular Junctional Rhythm","Left Bundle-Branch Block","Heart Failure, Systolic","Block;Atrioventricular","Block; Arrhythmic","Block; Mobitz","Block, Heart","Block, Fascicular","Block Branch Bundle Left","Heart Failure，Congestive","Heart Arrhythmia",[87,88,27,66,68,89,35,90,91,92,93,94,95,73,96,70,69,67],"Pace maker (PM)","Implantable cardioverter defibrillator (ICD)","Cardiac Resynchronization therapy","His Pacing","Left bundle branch area pacing (LBBAP)","CRT","CSP","Primary prevention","Secondary prevention","Heart failure","2024-03-19",{"date":99,"type":42},"2024-03-22",{"date":101,"type":42},"2023-01-01",{"date":103,"type":21},"2034-12-31",{"name":105,"class":106},"University Hospital of Ferrara","OTHER",31]