[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617083":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":46,"collaborators":50,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LBBAP","EXPERIMENTAL",null,[13],"Device: LBBAP",{"label":15,"type":16,"description":11,"interventionNames":17},"MVP","ACTIVE_COMPARATOR",[18],"Device: MVP",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","* All pacemaker implantation should be performed in standard manner.\n* A lead should be placed in the right atrial appendage or septum where acceptable sensing (P wave \\>1mV) and pacing threshold (\\\u003C1V at 0.4ms width).\n* V lead should be placed in the right ventricular septum where conduction system pacing can be achieved with acceptable sensing and pacing threshold. The pacing morphology should be compatible with His bundle pacing, right ventricular pacing, selective and non-selective left bundle branch pacing, or left fascicular pacing.\n* The primary objective for the LBBAP group is the achievement of conduction system capture with LBBAP. However, based on the physician's discretion or the situations in the operating room, His bundle pacing can be accepted as alternatives to LBBAP.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"* All pacemaker implantation should be performed in standard manner.\n* A lead should be placed in the right atrial appendage or septum where acceptable sensing (P wave \\>1mV) and pacing threshold (\\\u003C1V at 0.4ms width).\n* V lead should be placed in the right ventricular apex or septum where acceptable sensing (R wave \\>5mV) and pacing threshold (\\\u003C1V at 0.4ms width)\n* The rhythmiQTM mode should be turned on\n* Sensing and pacing AV intervals recommended to be \\>300ms (default value or more), and should not be \\\u003C200ms to minimize the ventricular pacing.",[15],[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":11,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Seoul","Songpa-gu","05505","South Korea",{"type":35,"coordinates":36},"Point",[37,38],126.9784,37.566,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Gi-byoung Nam","CONTACT","+82 2-3010-3167","gbnam1@gmail.com",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Gi-Byoung Nam","professor",[51,53,55],{"name":52,"class":6},"Severance Hospital",{"name":54,"class":6},"Samsung Medical Center",{"name":56,"class":6},"Seoul National University Hospital","100617083","left-bundle-branch-versus-minimized-ventricular-pacing-in-patients-with-sick-sinus-syndrome-and-prolonged-av-interval-100617083",false,"NCT07314008","Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval","Comparison of Left Bundle Branch Area Pacing and Minimized Ventricular Pacing in Patients With Sinus Node Dysfunction and Atrioventricular Conduction Delay: A Multicenter, Randomized Controlled Clinical Trial","CLOSE-AV","Inclusion Criteria:\n\n* \\>18 years old\n* Sinus node dysfunction with symptoms\n* Atrioventricular conduction delay (PR interval \\> 200ms)\n\nExclusion Criteria:\n\n* Subject was unable to provide written informed consent or participate in long-term follow-up.\n* Permanent atrial fibrillation\n* Pre-existing cardiac implantable electronic device\n* Persistent advanced atrioventricular conduction disturbance (2:1 block, Mobitz type II, or 3rd degree)\n* Mechanical tricuspid valve\n* Ventricular septal defect or scar\n* Left ventricular ejection fraction \\\u003C 35% who indicated cardiac resynchronization therapy\n* Previous heart transplantation\n* Pregnant and\u002For lactating women\n* Life expectancy \\\u003C2 year\n* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period","ALL","18 Years",{"count":68,"type":69},440,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and prolonged AV interval. It will also evaluate the safety and feasibility of the LBBAP method in these patients.\n\nThe main questions it aims to answer is:\n\n\\*Is LBBAP with physiological AV interval better than Minimized Ventricular Pacing?\n\nResearchers will compare the LBBAP group (aiming for conduction system capture with physiological AV intervals) to the MVP group (aiming to minimize ventricular pacing with prolonged AV intervals) to evaluate the optimal pacing strategy.\n\nParticipants will:\n\n* Be randomly assigned to either the LBBAP group or the MVP group.\n* Undergo a pacemaker implantation procedure according to the specific criteria for their assigned group.\n* Visit the clinic for regular checkups to measure pacing function and ensure the device settings remain compliant with the study protocol.",[75,76],"Sick Sinus Syndrome","Atrioventricular Nodal Dysfunction","2025-12-23",{"date":79,"type":80},"2026-01-02","ACTUAL",{"date":82,"type":80},"2025-05-02",{"date":84,"type":69},"2029-01-31",{"name":5,"class":6},1]