[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636243":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Optimized pacing strategy","EXPERIMENTAL","Optimized Pacing Strategy\n\n* Definition of Optimal Heart Rate: After permanent pacemaker implantation, a hemodynamic evaluation will be performed using right heart catheterization with stepwise incremental pacing rates of 60, 70, 80, and 90 bpm. If the optimal heart rate is identified at one of these 10-bpm intervals, additional assessments will be conducted in 5-bpm increments around that rate to further refine the optimal pacing rate.\n* Invasive hemodynamic parameters assessed include: Mean pulmonary capillary wedge pressure, Cardiac output (thermodilution)\n* The optimal heart rate is defined as the pacing rate associated with the lowest mean pulmonary capillary wedge pressure or highest cardiac output.\n* To ensure hemodynamic stabilization, a 5-minute washout period will be applied between rate changes.\n* To minimize the confounding effects of intrinsic bradycardia below 60 bpm, optimized pacing will be performed after a stabilization period of 2 weeks following permanent pacemaker.",[13],"Procedure: Adjustment of the pacemaker\u002FICDs lower rate limit (LRL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional pacing strategy","ACTIVE_COMPARATOR","Conventional Pacing Strategy\n\n• The conventional pacing group will have the pacemaker's lower rate limit set at a fixed 60 bpm, in accordance with current standard practice.",[19],"Procedure: Conventional lower rate (60bpm)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Adjustment of the pacemaker\u002FICDs lower rate limit (LRL)","Optimized Pacing Strategy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional lower rate (60bpm)","Conventional Pacing Strategy",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Juwon Kim, MD","CONTACT","82-10-2079-8154","abcd186a@naver.com",[38],{"facility":5,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Seoul","06351","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":51,"phoneExt":26,"email":36},"82-2-3410-3419",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Juwon Kim","Clinical Assitant Professor","100636243","impact-of-optimized-pacing-strategies-on-clinical-and-hemodynamic-outcomes-in-heart-failure-patients-with-pacemaker-100636243",false,"NCT07563153","Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker","Clinical and Hemodynamic Outcomes of OPTimized PACing StratEgies in Heart Failure Patients With Pacing Indications: Randomized-Controlled Trial (OPTPACE-HF)","OPTPACE-HF","Inclusion Criteria:\n\n* Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:\n\n  1. Sick sinus syndrome with or without impaired atrioventricular conduction\n  2. Persistent or permanent atrial fibrillation with slow ventricular response\n  3. Chronotropic incompetence\n* Patients diagnosed with heart failure with left ventricular ejection fraction ≥ 50% on transthoracic echocardiography with at least one of the following:\n* H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5\n* N-terminal pro-B-type natriuretic peptide ≥ 300 pg\u002FmL (sinus rhythm) or ≥ 600 pg\u002FmL (atrial fibrillation)\n* Prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms\n\nExclusion Criteria:\n\n* Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular pacing, His bundle pacing, and left bundle branch area pacing.\n\n(Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.)\n\n* Patients not expected to achieve sufficient pacing dependency, defined as:\n\n  1. In sinus rhythm: baseline atrial rate \\> 60 bpm on Holter monitoring or inpatient ECG monitoring\n  2. In atrial fibrillation\u002Fflutter: baseline ventricular rate \\> 60 bpm on Holter monitoring or inpatient ECG monitoring\n* Patients with contraindications to permanent pacemaker implantation\n* Patients with moderate or greater valvular stenosis or regurgitation.\n* Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions\n* Pregnant or breastfeeding women.\n* Patients who have refused active treatment.","ALL","19 Years",{"count":67,"type":68},106,"ESTIMATED","INTERVENTIONAL",[71],"NA","This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure.\n\n* Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart rate.\n* Primary Endpoint: Heart failure symptoms, assessed by the Kansas City Cardiomyopathy Questionnaire score.\n* Hypothesis: In patients with heart failure requiring permanent pacing, an optimized pacing strategy will lead to a significant improvement in heart failure symptoms (Kansas City Cardiomyopathy Questionnaire score) at 12 months compared with the conventional pacing strategy.",[74,75],"Heart Failure","Bradycardia",[77,78,79,80],"Heart failure","bradycardia","CIED","lower rate","2026-04-28",{"date":83,"type":84},"2026-05-01","ACTUAL",{"date":86,"type":84},"2025-12-18",{"date":88,"type":68},"2028-12-31",{"name":5,"class":6},1]