[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507578":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":34,"collaborators":18,"id":36,"slug":18,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":18,"enrollmentInfo":44,"targetDuration":18,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":57,"whyStopped":18,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":18},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic pacemaker implantation","ACTIVE_COMPARATOR","Brady-pacemaker implantation prior the TAVI-procedure. Pacemaker modus is according to local conditions.",[13],"Device: Prophylactic pacemaker implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Pacemaker implantation after TAVI if atrioventricular block occurs.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Pacemaker implantation prior the TAVI-procedure",[9],[25],{"name":26,"affiliation":5,"role":27},"Ashkan Eftekhari","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Ashkan Eftekhari, MD PhD","CONTACT","+4597664465","asef@rn.dk",{"type":27,"investigatorFullName":26,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Consultant ass. professor MD PhD","100507578",false,"NCT05889208","Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation","TAVI-PACE","Inclusion Criteria:\n\n* Patients undergoing TAVI indicated by severe valvular aortic stenosis\n* Written informed consent\n* Left ventricular ejection fraction ≥ 40 %\n* Persistent RBBB in 12-lead electrocardiogram (RSR' pattern in V1-3, QRS duration \\> 120 milliseconds, and wide S wave in leads I, aVL, V5-6)\n\nExclusion Criteria:\n\n* Other indications for pacemaker implantation or previously implanted pacemaker\n* Life expectancy \\\u003C 1 year\n* No written informed consent","ALL","70 Years",{"count":45,"type":46},320,"ESTIMATED","INTERVENTIONAL",[49],"NA","The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:\n\n* Prophylactic pacemaker implantation prior TAVI\n* Conservative strategy",[52,53],"Aortic Stenosis","Right Bundle-Branch Block",[55,56],"Trans-catheter aortic valve implantation","Pacemaker","NOT_YET_RECRUITING","2023-05-26",{"date":60,"type":61},"2023-06-05","ACTUAL",{"date":63,"type":46},"2023-12-01",{"date":65,"type":46},"2027-12-01",{"name":5,"class":6}]