[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581386":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":18,"responsibleParty":79,"collaborators":7,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":7,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":7,"maxAge":7,"enrollmentInfo":89,"targetDuration":7,"studyType":92,"phases":7,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":49,"whyStopped":7,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",null,[9,14],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"KaDirr Shemsi","CONTACT","+86-176-2130-9203","kadirr@lifetechmed.com",{"name":15,"role":11,"phone":16,"phoneExt":7,"email":17},"Jiaxuan Fu","86+13973207184","fujiaxuan@lifetechmed.com",[19,31,39,47,63,71],{"facility":20,"status":21,"city":22,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":7},"G.V.M.Carint Hospital","NOT_YET_RECRUITING","Myszków","Poland","PL",{"type":26,"coordinates":27},"Point",[28,29],19.32461,50.5752,{"lat":29,"lon":28},{"facility":32,"status":21,"city":33,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":34,"geoPoint":38,"contacts":7},"Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim","Oświęcim",{"type":26,"coordinates":35},[36,37],19.21037,50.03437,{"lat":37,"lon":36},{"facility":40,"status":21,"city":41,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":42,"geoPoint":46,"contacts":7},"Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok","Sanok",{"type":26,"coordinates":43},[44,45],22.2056,49.55573,{"lat":45,"lon":44},{"facility":48,"status":49,"city":50,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group","RECRUITING","Tychy",{"type":26,"coordinates":52},[53,54],18.96641,50.13717,{"lat":54,"lon":53},[57,60],{"name":58,"role":11,"phone":7,"phoneExt":7,"email":59},"Przemyslaw Weglarz","pweglarz@gmail.com",{"name":61,"role":11,"phone":7,"phoneExt":7,"email":62},"Ewa Konarska Kuszewska","ewakonku@gmail.com",{"facility":64,"status":21,"city":65,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":66,"geoPoint":70,"contacts":7},"Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group","Ustroń",{"type":26,"coordinates":67},[68,69],18.80198,49.72153,{"lat":69,"lon":68},{"facility":72,"status":21,"city":73,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":74,"geoPoint":78,"contacts":7},"Dr. Tytus Chałubiński County Hospital","Zakopane",{"type":26,"coordinates":75},[76,77],19.94885,49.29899,{"lat":77,"lon":76},{"type":80,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100581386","cera-asd-occluder-post-market-clinical-follow-up-study-100581386",false,"NCT06849635","Cera™ ASD Occluder Post-Market Clinical Follow-Up Study","Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).\n* Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.\n* Patients or legally authorized representative are willing to the collection and processing of his\u002Fher data or sign the Informed Consent.\n\nExclusion Criteria:\n\n* Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.\n* Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.\n* Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.\n* Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).\n* Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.\n* Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.\n* Patients did not conduct any follow up visit after hospital discharge.","ALL",{"count":90,"type":91},139,"ESTIMATED","OBSERVATIONAL","The objective of this post-market study is to:\n\n* collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder\n* identify previously unknown side-effects",[95],"Atrial Septal Defect",[95],"2025-03-03",{"date":99,"type":100},"2025-03-06","ACTUAL",{"date":102,"type":100},"2025-01-03",{"date":104,"type":91},"2026-02-28",{"name":5,"class":6},6]