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Master",{"facility":266,"status":81,"city":267,"state":233,"zip":268,"country":48,"countryCode":49,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","325000",{"type":51,"coordinates":270},[271,272],120.66682,27.99942,{"lat":272,"lon":271},[275,278,280],{"name":276,"role":36,"phone":277,"phoneExt":25,"email":25},"Huafang Chen","0577-55579590",{"name":279,"role":33,"phone":25,"phoneExt":25,"email":25},"Hao Zhou, Doctor",{"name":281,"role":64,"phone":25,"phoneExt":25,"email":25},"Xue Xia, Master",{"type":283,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100498748","safety-and-efficacy-of-cera-patent-foramen-ovale-occluders-100498748",false,"NCT05774288","Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.","A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.","Inclusion Criteria:\n\n1. Patients aged 18-60 years;\n2. Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;\n3. Patent foramen ovale was confirmed by at least one of the following conditions exists:\n\n   1. Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);\n   2. The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);\n4. It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:\n\n   1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;\n   2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;\n   3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;\n   4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.\n\nExclusion Criteria:\n\n1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\\> 50%);\n2. Large cerebral infarction occurred within 4 weeks (MR\u002FCT or DWI image ASPECTS score \\\u003C6 points or infarction volume ≥70 ml or infarction area \\> 1\u002F3 middle cerebral artery blood supply area);\n3. Patients with intracardiac thrombosis or tumor, intracardiac vegetations;\n4. Acute myocardial infarction or unstable angina within 6 months;\n5. Left ventricular aneurysm formation or left ventricular wall movement disorder;\n6. Mitral\u002Faortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;\n7. Dilated cardiomyopathy, LVEF \\\u003C 35%, or other severe heart failure;\n8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;\n9. Atrial fibrillation\u002Fatrial flutter (chronic or intermittent);\n10. Pregnant or planning to become pregnant during the trial;\n11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;\n12. Pulmonary hypertension or patent foramen ovale was a special channel;\n13. Liver and kidney function impairment (ALT or AST \\> 3 times the upper limit of normal value, serum creatinine (Cr) \\> 2 times the upper limit of normal value);\n14. Uncontrolled hypertension (\\> 180\u002F100 mmHg);\n15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;\n16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;\n17. The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;\n18. Thrombosis exists at the location or route of implantation;\n19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;\n20. Patients who could not be followed up during the trial;\n21. Participate in clinical trials of other drugs or medical devices within three months.","ALL","18 Years","60 Years",{"count":295,"type":296},244,"ESTIMATED","INTERVENTIONAL",[299],"NA","To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;",[302,303],"Patent Foramen Ovale","Cryptogenic Stroke","2023-08-31",{"date":306,"type":307},"2023-09-01","ACTUAL",{"date":309,"type":307},"2023-06-08",{"date":311,"type":296},"2029-06-30",{"name":5,"class":6},14]