[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-annuloplasty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-annuloplasty":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100626363","phase-3-apixaban-vs-warfarin-in-af-pts-first-three-months-after-repair-or-bio-avr-mvr-100626363",false,"NCT07434661","Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR","Safety and Efficacy of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in the First Three Months After Mitral or Aortic Biological Valve Replacement or Repair","SAFE-HEART","Inclusion Criteria:\n\n* Age ≥18 years at the time of enrolment\n* Open heart aortic or mitral valve repair or biological valve replacement in the last 10 days\n* Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),\n* Informed consent from either the patient or a substitute decision-maker.\n\nExclusion Criteria:\n\n* Mechanical valve replacement\n* Antiphospholipid syndrome (triple positive)\n* Severe renal failure (Cockcroft-Gault equation; creatinine clearance \\\u003C15 ml\u002Fmin)\n* Known significant liver disease (Child-Pugh classification B and C)\n* Left ventricular thrombus\n* Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis\n* Known contraindication for any DOAC or VKA\n* Women who are pregnant, breastfeeding, or of childbearing potential\n* Follow-up not possible","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","SAFE-HEART is a single-centre, randomized controlled trial comparing the safety and efficiency of Apixaban versus Warfarin in the early period (3 months) after repair or bioprosthetics of the mitral and aortic valve cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.",[27,28,29,30,31,32,33],"Valve Disease, Heart","Atrial Fibrillation (AF)","Valve Replacement Surgery","Aortic Valve Surgery","Mitral Valve Annuloplasty","Mitral Valve Repair","Mitral Valve Surgery",[35,36,37,38,39,40,41],"anticoagulation","bioprosthetics","atrial fibrillation","mitral valve repair","aortic valve repair","Apixaban","Warfarin","NOT_YET_RECRUITING","2026-02-20",{"date":45,"type":46},"2026-02-25","ACTUAL",{"date":48,"type":21},"2026-02",{"date":50,"type":21},"2029-01",{"name":52,"class":53},"Meshalkin Research Institute of Pathology of Circulation","NETWORK"]