Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Exclusion Criteria

• •1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\> 50%);
• •2. Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score \<6 points or infarction volume ≥70 ml or infarction area \> 1/3 middle cerebral artery blood supply area);
• •3. Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
• •4. Acute myocardial infarction or unstable angina within 6 months;
• •5. Left ventricular aneurysm formation or left ventricular wall movement disorder;
• •6. Mitral/aortic 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;
• •7. Dilated cardiomyopathy, LVEF \< 35%, or other severe heart failure;
• •8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
• •9. Atrial fibrillation/atrial flutter (chronic or intermittent);
• •10. Pregnant or planning to become pregnant during the trial;
• •11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
• •12. Pulmonary hypertension or patent foramen ovale was a special channel;
• •13. 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);
• •14. Uncontrolled hypertension (\> 180/100 mmHg);
• •15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
• •16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
• •17. 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;
• •18. Thrombosis exists at the location or route of implantation;
• •19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
• •20. Patients who could not be followed up during the trial;
• •21. Participate in clinical trials of other drugs or medical devices within three months.