[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620690":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":48,"collaborators":51,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Institute of Cardiovascular Diseases, Vojvodina","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AF patients submitted to cardiac surgery","EXPERIMENTAL","Participants in this arm are patients with atrial fibrillation undergoing cardiac surgery for a clinical indication and with a CHA₂DS₂-VASc score of 2 or greater. During the planned cardiac surgical procedure, surgical closure of the left atrial appendage is performed using the CE-marked AtriLASH suture-based device. The intervention is carried out as part of the same operative session and in addition to the indicated cardiac surgery. All participants receive the same intervention.",[13],"Device: LAA closure using the AtriLASH",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","LAA closure using the AtriLASH","The intervention consists of surgical closure of the left atrial appendage using the AtriLASH device during cardiac surgery. AtriLASH is a CE-marked, suture-based medical device made of Seralene material and is designed for epicardial closure of the left atrial appendage.\n\nThe device is applied intraoperatively as part of the planned cardiac surgical procedure in patients with atrial fibrillation. The left atrial appendage is identified and closed using the AtriLASH system according to the manufacturer's instructions for use. No additional incisions or separate procedures are required beyond those necessary for the indicated cardiac surgery.\n\nThe intervention is performed in all participants allocated to the study arm and is intended to achieve complete exclusion of the left atrial appendage to reduce the potential for blood stasis and thrombus formation.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lazar Velicki, MD, PhD","CONTACT","+381 21 4805701","lazar.velicki@ikvbv.ns.ac.rs",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":29},"Milos Matkovic, MD,PhD","dr.matko@hotmail.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Institute of cardiovascular diseases Vojvodina","RECRUITING","Kamenitz","Vojvodina","21204","Serbia","RS",{"type":40,"coordinates":41},"Point",[42,43],19.84263,45.22334,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":25,"phoneExt":20,"email":26},"Lazar Velicki",{"type":49,"investigatorFullName":47,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Professor, Senior Attending Cardiac Surgeon",[52,54,57],{"name":53,"class":6},"Institute for Cardiovascular Diseases Dedinje",{"name":55,"class":56},"KBC Rebro Zagreb","UNKNOWN",{"name":58,"class":6},"Clinical Centre of Serbia","100620690","atrial-fibrillation-trial-of-left-atrial-appendage-closure-using-seralene-hemostatic-suture-100620690",false,"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","ALL","18 Years",{"count":70,"type":71},200,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77,78,79,80,81],"ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION","Atrial Fibrillation (AF)","Mitral Valve Surgery","Stroke (in Patients With Atrial Fibrillation)","Anticoagulant Therapy","2026-01-14",{"date":84,"type":85},"2026-01-22","ACTUAL",{"date":87,"type":85},"2025-12-01",{"date":89,"type":71},"2026-06-30",{"name":5,"class":6},1]