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Safety","Device and Investigational Procedure Related Serious Adverse Events (SAE)","7 days, 45 days and 6 months post procedure",[14],{"measure":15,"description":16,"timeFrame":17},"Device success","Confirmation of functional LAA closure","45 days",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Implantable device","EXPERIMENTAL","Endomatic SEPIOLA System",[31],"Device: SEPIOLA System",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":18},"DEVICE","SEPIOLA System","Implantation of the SEPIOLA device into the left atrial appendage.",[27],[39],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Boaz Schwarz","CONTACT","+972 (0)544595839","boaz@endomaticmed.com",[45,58,64,79,93],{"facility":46,"status":47,"city":48,"state":18,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":18},"Israeli-Georgian Medical Research Clinic Helsicore","COMPLETED","Tbilisi","0112","Georgia","GE",{"type":53,"coordinates":54},"Point",[55,56],44.83412,41.69143,{"lat":56,"lon":55},{"facility":59,"status":47,"city":48,"state":18,"zip":60,"country":50,"countryCode":51,"cosmosGeoPoint":61,"geoPoint":63,"contacts":18},"Tbilisi Heart and Vascular Clinic","0159",{"type":53,"coordinates":62},[55,56],{"lat":56,"lon":55},{"facility":65,"status":66,"city":67,"state":18,"zip":18,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Vilnius university hospital Santaros Klinikos","RECRUITING","Vilnius","Lithuania","LT",{"type":53,"coordinates":71},[72,73],25.2798,54.68916,{"lat":73,"lon":72},[76],{"name":77,"role":41,"phone":18,"phoneExt":18,"email":78},"Gediminas Račkauskas, MD","Gediminas.Rackauskas@santa.lt",{"facility":80,"status":66,"city":81,"state":18,"zip":18,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Uniwersytecki Szpital Kliniczny w Poznaniu","Poznan","Poland","PL",{"type":53,"coordinates":85},[86,87],16.92993,52.40692,{"lat":87,"lon":86},[90],{"name":91,"role":41,"phone":18,"phoneExt":18,"email":92},"Marek Grygier, MD","marek.grygier@usk.poznan.pl",{"facility":94,"status":66,"city":95,"state":18,"zip":18,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Ezgu Niyat","Tashkent","Uzbekistan","UZ",{"type":53,"coordinates":99},[100,101],69.21627,41.26465,{"lat":101,"lon":100},[104],{"name":105,"role":41,"phone":18,"phoneExt":18,"email":18},"Askar Sabirov, MD",{"type":107,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100523700","safety-and-performance-of-endomatic-sepiola-left-atrial-appendage-laa-closure-device-100523700",false,"NCT06099106","Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device","Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation","Inclusion Criteria:\n\n* calculated CHA2DS2-VASc score of 2 or greater.\n* The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.\n* documented non-valvular atrial fibrillation\n* Subject suitable for vascular\u002Fcardiac intervention procedure\n* suitable LAA anatomical measurements for study device\n\nExclusion Criteria:\n\n* Subject who requires anticoagulation for a condition other than AF.\n* NYHA classification IV.\n* Complex congenital heart disease.\n* Presence of circumflex coronary artery stent.\n* The subject has a prosthetic valve in any position.\n* atrial septal defect closure or has an ASD\u002FPFO device.\n* presence of intracardiac thrombus.\n* Any cardiac surgery in the past\n* LVEF \\\u003C 35%.\n* intracardiac thrombus\n* moderate or severe mitral valve stenosis","ALL","18 Years",{"count":118,"type":119},15,"ESTIMATED","INTERVENTIONAL",[20],"The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.\n\nPotential patients who are candidates for LAA closure will be screened to confirm that all inclusion\u002Fexclusion criteria are met, with final eligibility confirmation on day of procedure.\n\nAll enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.\n\nAdditional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.",[124],"Atrial Fibrillation","2025-08-13",{"date":127,"type":128},"2025-08-17","ACTUAL",{"date":130,"type":128},"2023-05-01",{"date":132,"type":119},"2027-05",{"name":5,"class":6},5]