[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sinus-node-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sinus-node-dysfunction":28},{"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":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100619774","predicting-severe-cardiac-arrhythmias-in-the-perioperative-period-using-ai-ecg-100619774","NCT07348991","Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG","Predicting Atrial Fibrillation and Life-threatening Cardiac Arrhythmias and Conduction Disorders in the Perioperative Period in High Cardiac Risk Surgery Using Artificial Intelligence Elements","Inclusion Criteria:\n\n* Patients over 18 years of age;\n* Scheduled surgery with high cardiac risk\n* Informed consent was given to participate in the study\n\nExclusion Criteria:\n\n* Cancellation of the surgery for any reason;\n* The patient's unwillingness to continue participating in the study;\n* Poor quality of the ECG recording on a single-channel ECG monitor.",{"count":59,"type":21},300,"During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices. This ECG is analyzed for time, amplitude, and frequency parameters-more than 200 parameters per cardiac cycle. Additionally, the available parameters of a standard 12-lead ECG recording are determined. All parameters of both single-lead and 12-lead ECGs will be included in a multivariate regression analysis to determine the optimal method for predicting atrial fibrillation, life-threatening cardiac arrhythmias, and conduction abnormalities in the perioperative period after high-risk cardiac procedures.\n\nThe study will include patients undergoing high-risk cardiac surgeries, such as those on the heart, aorta, esophagus, pancreas, liver, and lungs, as well as high-risk oncological surgeries. A partial analysis will also be performed depending on the type of intervention. Rhythm and conduction disturbances will be recorded during surgery, as well as in the postoperative period, using ECG monitors, 24-hour ECG monitoring, and repeated recordings of a standard ECG when complaints or signs of unstable hemodynamics arise",[62,63,28,64,65],"Atrial Fibrillation","Atrioventricular Block, Second and Third Degree","Ventricular Tachycardia (VT)","Ventricular Fibrillation",[67,68,69,70,71,72],"Electrocardiogram","Artificial intelligence","Cardiac arrhythmias","Atrioventricular block","Perioperative","Atrial fibrillation","NOT_YET_RECRUITING","2026-02-09",{"date":76,"type":42},"2026-02-10",{"date":78,"type":21},"2026-12-31",{"date":80,"type":21},"2028-05-30",{"name":82,"class":83},"I.M. Sechenov First Moscow State Medical University","OTHER"]