[{"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":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":18,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"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","prophylactic-permanent-pacemaker-in-patients-with-right-bundle-branch-block-undergoing-transcatheter-aortic-valve-implantation-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":46,"type":47},320,"ESTIMATED","INTERVENTIONAL",[50],"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",[53,54],"Aortic Stenosis","Right Bundle-Branch Block",[56,57],"Trans-catheter aortic valve implantation","Pacemaker","NOT_YET_RECRUITING","2023-05-26",{"date":61,"type":62},"2023-06-05","ACTUAL",{"date":64,"type":47},"2023-12-01",{"date":66,"type":47},"2027-12-01",{"name":5,"class":6}]