[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":33,"responsibleParty":53,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Luebeck","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental intervention","EXPERIMENTAL","Percutaneous closure of the LAA by use of the CE-mark approved LAA exclusion device Amplatzer Cardiac Plug or Amulet followed by dual antiplatelet therapy with aspirin 100mg od and clopidogrel 75 mg od for 3 months. In patients with excessive bleeding risk DAPT duration can be shortened according to the physicians' discretion to a minimum of 6 weeks. Oral anticoagulants are not prescribed in this group.",[13],"Other: Left Atrial Appendage closure",{"label":15,"type":16,"description":17,"interventionNames":18},"Control intervention","NO_INTERVENTION","No catheter-based LAA closure. Treatment with best medical care (warfarin or NOAC therapy or other best medical care if (N)OAC therapy is contraindicated).",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Left Atrial Appendage closure","Percutaneous closure of the LAA",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Ingo Eitel, MD","CONTACT","+49 451 500 44501","ingo.eitel@uksh.de",{"name":31,"role":27,"phone":28,"phoneExt":18,"email":32},"Thomas Stiermaier, MD","thomas.stiermaier@uksh.de",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Universität zu Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],10.68729,53.86893,{"lat":46,"lon":45},[49,51],{"name":50,"role":27,"phone":18,"phoneExt":18,"email":18},"Ingo Eitel, Prof. Dr. med.",{"name":52,"role":27,"phone":18,"phoneExt":18,"email":18},"Thomas Stiermaier, Dr.med",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Director","100454951","left-atrial-appendage-closure-in-patients-with-non-valvular-atrial-fibrillation-and-end-stage-chronic-kidney-disease-100454951",false,"NCT05204212","Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease","Prospective, Randomized, Controlled, Unblinded, International, Multicentre, Parallel Two Group Trial of Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage","LAA-KIDNEY","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to give informed consent\n* Documented NVAF (paroxysmal, persistent, or permanent)\n* CHA2DS2VASc risk score ≥2\n* Chronic kidney disease KDOQI stage 5 (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2) with or without hemodialysis\n\nExclusion Criteria:\n\n* Absolute contraindication to aspirin and\u002For clopidogrel\n* Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis\n* Present LAA thrombus\n* Mobile aortic atheroma\n* Age ≤18 years\n* Patients presenting with pregnancy\n* Patients without informed consent\n* Participation in another trial\n* Expected life expectancy \\\u003C2 years","ALL","18 Years",{"count":68,"type":69},430,"ESTIMATED","INTERVENTIONAL",[72],"NA","In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and\u002For Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.",[75],"Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent","2024-05-10",{"date":78,"type":79},"2024-05-13","ACTUAL",{"date":81,"type":79},"2022-03-28",{"date":83,"type":69},"2028-01-14",{"name":55,"class":6},1]