[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Hangzhou Dinova EP Technology Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment group","EXPERIMENTAL","Percutaneously occlusion of PFO with SnowyTM PFO closure system",[13],"Device: SnowyTM PFO closure system",{"label":15,"type":10,"description":16,"interventionNames":17},"control group","Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder",[18],"Device: Cardi-o-fix PFO occluder",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE","SnowyTM PFO closure system",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"Cardi-o-fix PFO occluder",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Kong Xiangqing, MD","CONTACT","+8602563806360","xiangqing_kong@sina.com",[35],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital of Nanjing Medical University","Nanjing","Jiangsu","210029","China","CN",{"type":43,"coordinates":44},"Point",[45,46],118.77778,32.06167,{"lat":46,"lon":45},[49,50,53],{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":51,"role":52,"phone":24,"phoneExt":24,"email":24},"Peng Xiaoping, MD","SUB_INVESTIGATOR",{"name":54,"role":52,"phone":24,"phoneExt":24,"email":24},"Cheng Ziying, MD",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100466978","study-on-the-safety-and-effectiveness-of-the-snowytm-pfo-closure-system-100466978",false,"NCT05360771","Study on the Safety and Effectiveness of the SnowyTM PFO Closure System","A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the SnowyTM PFO Closure System in Plugging Patent Foramen Ovale","Inclusion Criteria:\n\n1. Age: 18 to 65 years old, regardless of gender\n2. Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active\u002Fresting state)\n3. Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine\n4. The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination\n\nExclusion Criteria:\n\n1. Patients have definite causes of stroke unrelated to the PFO\n2. RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt\n3. Atrial fibrillation or atrial flutter\n4. Mitral and aortic stenosis or severe regurgitation\n5. Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy\n6. Active endocarditis or other untreated infectious diseases\n7. Left ventricular ejection fraction (LVEF) \\\u003C 40%, or NYHA cardiac function grade III-IV\n8. Uncontrollable hypertension\n9. Previous intracardiac surgery\n10. Myocardial infarction or unstable angina pectoris within 6 months\n11. Contraindications to anticoagulants or antiplatelet drugs\n12. High risk of bleeding\n13. severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）\n14. Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation\n15. Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)\n16. Nickel or contrast allergy\n17. Active or planned (within 12 months) pregnancy, or lactating female patients\n18. Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months\n19. Psychiatric conditions that may interfere with medical compliance and compliance with follow-up\n20. Concomitant participation in other clinical trials\n21. The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation","ALL","18 Years","65 Years",{"count":68,"type":69},242,"ESTIMATED","INTERVENTIONAL",[72],"NA","To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale",[75],"Patent Foramen Ovale","NOT_YET_RECRUITING","2023-06-05",{"date":79,"type":80},"2023-06-07","ACTUAL",{"date":82,"type":69},"2023-10-20",{"date":84,"type":69},"2027-12-20",{"name":5,"class":6},1]