[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":4},"100654761","procedural-endpoint-in-left-bundle-branch-area-pacing-conduction-system-capture-versus-lv-septal-capture-100654761",false,"NCT07804394","Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture","COMparisons of Different Procedural endPoints in pAtients Who undeRgo Left Bundle Branch arEa Pacing: Direct Capture of Left Ventricular Conduction SYstem Versus Left veNtricular Septal Capture (COMPARE-SYNC): A Multicenter, Prospective, Randomized Controlled Study","COMPARE-SYNC","Inclusion Criteria\n\n1. Patients with a guideline-based indication for permanent pacemaker implantation for bradyarrhythmia and an expected ventricular pacing burden (VP) of 40% or more.\n2. Patients in whom a left bundle branch area pacing (LBBAP) procedure is planned in accordance with the above indication.\n3. Age 19 years or older.\n4. Provision of written informed consent to participate in the study.\n\nExclusion Criteria\n\n1. Inability to understand the study or unwillingness to consent to participation.\n2. History of mechanical tricuspid valve replacement.\n3. History of myocardial infarction involving the interventricular septum.\n4. Life expectancy of 12 months or less.\n5. Inability to complete 12 months of follow-up for any reason.\n6. Pregnancy.\n7. History of cardiac transplantation.\n8. Indication for cardiac resynchronization therapy (CRT), defined as LVEF \\\u003C=35% and QRS duration \\>=130 ms with left bundle branch block and NYHA functional class II to IV. This population is the subject of a separate randomized CRT trial and is distinct from the non-CRT pacemaker population studied here.\n9. Presence of an existing permanent pacemaker, implantable cardioverter-defibrillator, or CRT device (procedures performed for device replacement are not eligible).","ALL","19 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter, randomized controlled trial designed to determine whether direct capture of the left ventricular conduction system must be achieved as the procedural endpoint of left bundle branch area pacing (LBBAP), or whether left ventricular septal capture alone is sufficient to obtain comparable clinical outcomes.\n\nA total of 300 patients aged 19 years or older who have a guideline-based indication for permanent pacemaker implantation for bradyarrhythmia, an expected ventricular pacing burden of 40% or more, and a planned LBBAP procedure will be enrolled at 5 or more centers in the Republic of Korea. Participants will be randomly assigned in a 1:1 ratio, stratified by baseline left ventricular ejection fraction (LVEF \\\u003C50% versus \\>=50%), to one of two procedural strategies:\n\n1. LBBP mandatory group - the implanting operator continues the procedure, repositioning the lead as required, until left bundle branch pacing (LBBP) or left fascicular pacing (LFP) is confirmed by at least one predefined conduction system capture criterion.\n2. LVSP enough group - the operator may complete the procedure at his or her discretion once left ventricular septal pacing (LVSP) is confirmed, irrespective of whether direct conduction system capture is achieved.\n\nThe same commercially approved lead and pulse generator platform is used in both groups, so the randomized variable is the procedural endpoint strategy rather than the device.\n\nThe primary outcome measure is the absolute change in LVEF from baseline to 12 months, adjudicated by a blinded central echocardiography core laboratory. Secondary outcome measures include echocardiographic response, pacing-induced cardiomyopathy, procedure-related major complications, procedure and fluoroscopy time, paced QRS duration, acute procedural success, achievement and long-term maintenance of conduction system capture, all-cause death, cardiovascular death, heart failure hospitalization, upgrade to cardiac resynchronization therapy, and new-onset atrial fibrillation.\n\nAll participants are followed for 12 months after implantation, with study visits at 2 weeks to 1 month, 6 months, and 12 months. The primary analysis follows the intention-to-treat principle, with a prespecified per-protocol analysis according to whether conduction system capture was actually achieved.",[27,28,29,30,31,32,33,34,35,36],"Bradycardia","Atrioventricular Block","Sick Sinus Syndrome","Cardiac Pacing","Artificial","Heart Conduction System","Bundle-Branch Block","Ventricular Dysfunction","Left","Cardiomyopathies",[38,39,40,41,42,43,44,45,46,47,48,49],"LBBAP (left bundle branch area pacing)","LBBP (left bundle branch pacing)","LFP (left fascicular pacing)","LVSP (left ventricular septal pacing)","CSP (conduction system pacing)","DSP (deep septal pacing)","PICM (pacing-induced cardiomyopathy)","LVEF","paced QRS duration","procedural endpoint","S-V6RWPT","V6-V1 interpeak interval","NOT_YET_RECRUITING","2026-09-01",{"date":53,"type":54},"2026-09-04","ACTUAL",{"date":56,"type":21},"2026-10-01",{"date":58,"type":21},"2029-11-30",{"name":60,"class":61},"Yonsei University","OTHER"]