Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale

Inclusion Criteria: 1. The subject is aged between 18 and 65 years old; 2. Patent foramen ovale (PFO) confirmed by imaging examination with moderate or greater right-to-left shunt (RLS) (both condition a and b shall be satisfied simultaneously):a) Patent foramen ovale (PFO) confirmed by echocardiography (TTE or TEE);b) Moderate or greater right-to-left shunt confirmed by contrast echocardiography (cTTE, cTEE or cTCD); 3. Diagnosed as PFO-related stroke/TIA after clinical exclusion of other etiologies; 4. The subject or legal guardian understands the trial purpose, voluntarily participates in the trial, signs the written informed consent form, and is willing to complete follow-up in accordance with the protocol requirements. Exclusion Criteria: 1. Carotid atherosclerotic stenosis (stenosis degree \>50% confirmed by ultrasound or CTA); 2. Large cerebral infarction within 4 weeks (defined by imaging as hypodense area on CT involving more than 1/2 of the MCA perfusion territory, or infarct volume\>145 ml on diffusion-weighted imaging (DWI)); 3. Intracardiac thrombus or tumor, intracardiac vegetation; 4. Acute myocardial infarction or unstable angina within 6 months; 5. Presence of left ventricular aneurysm or left ventricular wall motion abnormality; 6. Severe valvular heart disease, such as severe mitral regurgitation or stenosis, severe aortic regurgitation or stenosis, mitral or aortic valve vegetation; 7. Combined cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, etc.); 8. Severe heart failure with LVEF \<35%; 9. Pulmonary hypertension (mPAP \>25 mmHg); 10. Right-to-left shunt caused by other etiologies, including atrial septal defect or pulmonary arteriovenous fistula; 11. Concomitant atrial fibrillation or atrial flutter; 12. Active endocarditis or other untreated infections; 13. Thrombosis in the access vessel or conditions interfering with the normal deployment of the study device; 14. Hepatic and renal dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of normal, or serum creatinine (Cr) \>2 times the upper limit of normal); 15. Coagulopathy or contraindications to antiplatelet or anticoagulant therapy; 16. Pregnant or lactating females, or those planning pregnancy during the trial period; 17. The investigator judges that the PFO anatomy is unsuitable for occluder implantation or suture repair with the suture system, or has contraindications to PFO occlusion/suture treatment; 18. Malignant tumor or other diseases with life expectancy less than 1 year; 19. Participation in another clinical trial with trial endpoints not yet reached; 20. Other conditions deemed inappropriate for enrollment in this trial by the investigator.