[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508030":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":63,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":11,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":89,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional pacing","ACTIVE_COMPARATOR",null,[13],"Device: Conventional pacing",{"label":15,"type":16,"description":11,"interventionNames":17},"LBB pacing","EXPERIMENTAL",[18],"Device: Left bundle branch pacemaker",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Left bundle branch pacemaker","Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.",[15],{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \\\u003C 40 %",[9],[29],{"facility":5,"status":11,"city":30,"state":11,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Ljubljana","1000","Slovenia","SI",{"type":35,"coordinates":36},"Point",[37,38],14.50513,46.05108,{"lat":38,"lon":37},[41,46,48,51,53,55,57,59,61],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Klemen Steblovnik, MD, PhD","CONTACT","0038615228529","steblovnik@gmail.com",{"name":42,"role":47,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":49,"role":50,"phone":11,"phoneExt":11,"email":11},"David Zizek, MD, PhD","SUB_INVESTIGATOR",{"name":52,"role":50,"phone":11,"phoneExt":11,"email":11},"Matjaz Bunc, MD, PhD",{"name":54,"role":50,"phone":11,"phoneExt":11,"email":11},"Peter Marko Mihailovic, MD, PhD",{"name":56,"role":50,"phone":11,"phoneExt":11,"email":11},"Simon Terseglav, MD",{"name":58,"role":50,"phone":11,"phoneExt":11,"email":11},"Ana Kovac, MD, PhD",{"name":60,"role":50,"phone":11,"phoneExt":11,"email":11},"Anja Zupan Meznar, MD, PhD",{"name":62,"role":50,"phone":11,"phoneExt":11,"email":11},"Ljupka Dimitrovska, MD",{"type":47,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Klemen Steblovnik","Principal Investigator","100508030","conventional-versus-left-bundle-branch-pacing-in-tavi-100508030",false,"NCT05895097","Conventional Versus Left Bundle Branch Pacing in TAVI","Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation","Inclusion Criteria:\n\n* Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)\n* Left ventricular ejection fraction \\\u003C 50 %.\n\nExclusion Criteria:\n\n* Unsuccessful TAVI procedure with life expectancy \\\u003C 1 year\n* Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)\n* Severe kidney failure (glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n* Previous permanent pacemaker","ALL","18 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \\\u003C 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\\\u003C 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).",[83,84,85,86],"Aortic Valve Stenosis","Heart Failure","Pacemaker-Induced Cardiomyopathy","Transcatheter Aortic Valve Implantation",[86,88],"Left bundle branch pacing","NOT_YET_RECRUITING","2023-06-05",{"date":92,"type":93},"2023-06-08","ACTUAL",{"date":95,"type":77},"2023-06-15",{"date":97,"type":77},"2026-06-15",{"name":5,"class":6},1]