atrial septal defect
Conditions
Interventions
Group A:Biodegradable ASD occluder and Delivery System
Group B:ASD occluder and Delivery System
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Internal medicine: 1. Aged >= 3 years old. 2. Diameter >= 5mm, with right heart volume load increased, = 5mm; that to the atrioventricular valve >=7mm. 4. Diameter of the atrial septal defect>the diameter of the left side of the selected occluder. 5. Voluntarily participate in human clinical trials, sign informed consent, and follow up as required. surgical: 1. Usually age >= 6 months, weight >= 6kg; 2. Secondary type of ASD, diameter >= 5mm, with right heart volume load increased, = 5mm; that to the atrioventricular valve is >=7 mm. 4. The diameter of atrial septal defect is larger than the diameter of the left side of the selected occluder. 5. ASD combined with other cardiac malformations, but which can be treated under non-cardiopulmonary bypass, can be treated with a median sternal incision. For example: ASD combined with pulmonary stenosis, VSD, patent ductus arteriosus, coronary spasm and so on. 6. Residual shunt after surgery. 7. The femoral route is restricted, or the femoral vein is relatively thin which of child cannot let catheter pass through. 8. Voluntary participation in human clinical trials, signing informed consent, and follow-up as required.
Exclusion criteria
Exclusion criteria: Internal medicine: 1. ASD combined with other cardiovascular malformations which must undergo surgical treatment. 2. Septicemia in the last month or untreated systemic infection . 3. Patients with bleeding disorders and ulcers who are unable to maintain aspirin and other antiplatelet agents within 6 months. 4. Echocardiography revealed patients with intracardiac thrombosis (especially left atrial or left atrial appendage). 5. Due to weight and age and other conditions (such as active infections), patients are not suitable for cardiac catheterization. 6. Patient who are pregnant or breastfeeding, or plans pregnancy, do not agree to take effective contraceptive measures during the trial. 7. Patients who are considered unsuitable for this clinical trial according the investigator surgical: 1. Sinus type ASD. 2. endocarditis and bleeding disorders. 3. There is a thrombus in the occluder placement and a venous thrombosis at the catheter insertion. 4. Severe pulmonary hypertension leads to a right-to-left shunt. 5. With severe myocardial disease or valvular disease unrelated to ASD. 6. Infectious diseases in the last month, or infectious diseases that have not been controlled . 7. Suffering from bleeding disorders, or unhealed stomach, duodenal ulcer. 8. Left atrial or left atrial appendage thrombosis, partial or total pulmonary venous drainage, left atrial septum, left atrium or left ventricular dysplasia. 9. Patient who are pregnant or breastfeeding, or plans pregnancy, do not agree to take effective contraceptive measures during the trial. 10. Patients who are considered unsuitable for this clinical trial according the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Closure success rate;Overall success rate;Complication rate; | — |
Countries
China
Contacts
Public ContactSun Kun
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed