[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-surgery":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"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":54},"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",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":54},"100620690","atrial-fibrillation-trial-of-left-atrial-appendage-closure-using-seralene-hemostatic-suture-100620690","NCT07360899","Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture","Left Atrial Appendage Closure During Cardiac Surgery in Atrial Fibrillation Patients With Seralene","ATRI-LASH","Inclusion Criteria:\n\nAge 18 years or older\n\nDocumented atrial fibrillation (any type)\n\nCHA₂DS₂-VASc score of 2 or greater, or equivalent stroke risk\n\nScheduled to undergo cardiac surgery (including coronary artery bypass grafting, valve surgery, or other structural cardiac surgery)\n\nAbility to understand the study and provide written informed consent\n\nExclusion Criteria:\n\nContraindication to left atrial appendage closure (e.g., presence of left atrial appendage thrombus or unsuitable anatomy)\n\nLife expectancy less than 3 months, based on clinical judgment\n\nCurrent participation in another clinical study that could interfere with the outcomes of this study\n\nActive or suspected infective endocarditis",{"count":64,"type":21},200,[66],"NA","Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke. In patients with atrial fibrillation, blood clots most often form in a small structure of the heart called the left atrial appendage. If a blood clot travels from the heart to the brain, it can cause a stroke.\n\nBlood-thinning medications are commonly prescribed to reduce the risk of stroke in patients with atrial fibrillation. However, some patients cannot take these medications long-term because of bleeding risk, side effects, or other medical reasons.\n\nClosing the left atrial appendage is an alternative approach to reduce the risk of stroke by preventing blood from collecting in this area. When patients undergo cardiac surgery for another indication, closure of the left atrial appendage can be performed during the same operation.\n\nThis study is designed to evaluate the safety and effectiveness of surgical closure of the left atrial appendage using a device called AtriLASH during cardiac surgery. AtriLASH is a surgical suture-based device intended to close the left atrial appendage.\n\nThe study will assess whether the left atrial appendage can be safely and effectively closed using this method in patients with atrial fibrillation undergoing cardiac surgery. The information obtained from this study may help determine whether this approach can reduce the risk of stroke and potentially decrease the need for long-term use of blood-thinning medications in selected patients.",[69,28,33,70,71],"ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION","Stroke (in Patients With Atrial Fibrillation)","Anticoagulant Therapy","RECRUITING","2026-01-14",{"date":75,"type":46},"2026-01-22",{"date":77,"type":46},"2025-12-01",{"date":79,"type":21},"2026-06-30",{"name":81,"class":82},"Institute of Cardiovascular Diseases, Vojvodina","OTHER"]