Clinical Research Directory

Inclusion Criteria: 1. Aged≥3years, body weight≥10 kg, regardless of gender; 2. Patients with secundum atrial septal defect (ASD) with left-to-right shunt and evidence of right ventricular volume overload (echocardiography indicating right ventricular enlargement); 3. ASD diameter≥5 mm and\<26 mm; 4. The distance from the ASD rim to the openings of the superior/inferior vena cava and pulmonary veins≥5mm, and the distance to the atrioventricular valve≥7mm; 5. Patients who can understand the trial purpose, voluntarily participate and sign the informed consent form, and are willing to cooperate with follow-up completion. Exclusion Criteria: 1. Primum, sinus venosus, and unroofed coronary sinus types of atrial septal defect (ASD); 2. Patients with ASD diameter≥26 mm; 3. Combined with other structural heart diseases requiring treatment besides ASD; 4. Complicated with severe pulmonary hypertension or Eisenmenger syndrome; 5. Patients who suffered from infectious diseases within 1 month before enrollment, including infective endocarditis, or those with uncontrolled infectious diseases; 6. Patients who suffered from hemolysis, hemorrhagic diseases, unhealed peptic ulcer within 1 month before enrollment, or have any contraindications to aspirin therapy (except those who can take other antiplatelet drugs continuously for 6 months); 7. Intracardiac thrombus detected by echocardiography (especially thrombus in the left atrium or left atrial appendage), or venous thrombosis at the catheter insertion site; 8. Patients allergic to the materials of the investigational medical device; 9. Pregnant or lactating females, or those who plan to have children during the trial and are unwilling to adopt effective contraceptive measures; 10. Patients who participated in other drug or medical device clinical trials before enrollment and have not reached the primary endpoint; 11. Patients with other factors deemed inappropriate to participate in this clinical trial by the investigator.