[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570470":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":29,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":29,"enrollmentInfo":71,"targetDuration":29,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":43,"whyStopped":29,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Parc de Salut Mar","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Right Ventricle Apical Pacing","ACTIVE_COMPARATOR","Standard location for any pacing lead in the right ventricle",[13],"Device: Pacemaker and defibrillator",{"label":15,"type":16,"description":17,"interventionNames":18},"Left bundle branch pacing","EXPERIMENTAL","Stimulation in the Conduction System (righ ventricle) capturing the left budle branch",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Left septal pacing","Stimulation in the Conduction System (righ ventricle) without capturing the left budle branch",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Pacemaker and defibrillator","Pacemaker implantation, which can be a regular right ventricle apical lead or a LBBAP lead (LBBP or LVSP dependint on the criteria accomplished).",[15,20,9],null,[31,36],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Ermengol Valles, PhD","CONTACT","0034666437038","ermengolvalles@mac.com",{"name":37,"role":33,"phone":38,"phoneExt":29,"email":39},"Jesus Jimenez, MD","0034680714927","jejilo78@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":29,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital del Mar - IMIM","RECRUITING","Barcelona","08003","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],2.15899,41.38879,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":34,"phoneExt":29,"email":35},"Ermengol Vallès, PhD",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Ermengol Vallès","Director of Electrophysiology and Cardiac Stimulation Program","100570470","left-septal-pacing-or-left-bundle-branch-pacing-to-avoid-left-ventricle-systolic-dysfunction-100570470",false,"NCT06707662","Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction","Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators","STAY II","Inclusion Criteria:\n\n1. Age of 18 years or more.\n2. Preserved or mild deteriorated LVEF (Simpson \\>40%) assessed by a recent (\\\u003C1 month before implantation) transthoracic echocardiography.\n3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\\>80%).\n4. Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.\n\nExclusion Criteria:\n\n1. Patients with indication for implantable cardioverter defibrillator device.\n2. Patients with indication for a CRT device, with LVEF \\\u003C40%.\n3. Patients with previous severe LVD (Simpson LVEF \\\u003C30%) and a recovered LVEF.\n4. History of myocardial infarction\u002Frevascularization or cardiac surgery within 6 months before randomization.\n5. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.","ALL","18 Years",{"count":72,"type":73},150,"ESTIMATED","INTERVENTIONAL",[76],"NA","Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial).\n\nCriteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.",[79],"AV Block",[81,82,83,84,85,86],"Conduction System Pacing","Left bundle branch area pacing","Right ventricle apical pacing","Left septum pacing","Left ventricle ejection fraction","Heart failure","2025-02-10",{"date":89,"type":90},"2025-02-11","ACTUAL",{"date":92,"type":90},"2025-01-01",{"date":94,"type":73},"2026-12-01",{"name":5,"class":6},1]