[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581386":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":18,"responsibleParty":78,"collaborators":7,"id":80,"slug":7,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":7,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":7,"maxAge":7,"enrollmentInfo":87,"targetDuration":7,"studyType":90,"phases":7,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":48,"whyStopped":7,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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",[19,30,38,46,62,70],{"facility":20,"status":21,"city":22,"state":7,"zip":7,"country":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":7},"G.V.M.Carint Hospital","NOT_YET_RECRUITING","Myszków","Poland",{"type":25,"coordinates":26},"Point",[27,28],19.32461,50.5752,{"lat":28,"lon":27},{"facility":31,"status":21,"city":32,"state":7,"zip":7,"country":23,"cosmosGeoPoint":33,"geoPoint":37,"contacts":7},"Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim","Oświęcim",{"type":25,"coordinates":34},[35,36],19.21037,50.03437,{"lat":36,"lon":35},{"facility":39,"status":21,"city":40,"state":7,"zip":7,"country":23,"cosmosGeoPoint":41,"geoPoint":45,"contacts":7},"Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok","Sanok",{"type":25,"coordinates":42},[43,44],22.2056,49.55573,{"lat":44,"lon":43},{"facility":47,"status":48,"city":49,"state":7,"zip":7,"country":23,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group","RECRUITING","Tychy",{"type":25,"coordinates":51},[52,53],18.96641,50.13717,{"lat":53,"lon":52},[56,59],{"name":57,"role":11,"phone":7,"phoneExt":7,"email":58},"Przemyslaw Weglarz","pweglarz@gmail.com",{"name":60,"role":11,"phone":7,"phoneExt":7,"email":61},"Ewa Konarska Kuszewska","ewakonku@gmail.com",{"facility":63,"status":21,"city":64,"state":7,"zip":7,"country":23,"cosmosGeoPoint":65,"geoPoint":69,"contacts":7},"Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group","Ustroń",{"type":25,"coordinates":66},[67,68],18.80198,49.72153,{"lat":68,"lon":67},{"facility":71,"status":21,"city":72,"state":7,"zip":7,"country":23,"cosmosGeoPoint":73,"geoPoint":77,"contacts":7},"Dr. Tytus Chałubiński County Hospital","Zakopane",{"type":25,"coordinates":74},[75,76],19.94885,49.29899,{"lat":76,"lon":75},{"type":79,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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":88,"type":89},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",[93],"Atrial Septal Defect",[93],"2025-03-03",{"date":97,"type":98},"2025-03-06","ACTUAL",{"date":100,"type":98},"2025-01-03",{"date":102,"type":89},"2026-02-28",{"name":5,"class":6},6]