Atrial Septal Defect
Conditions
Interventions
Group A:Biodegradable atrial septal defect occluder
Group B:Atrial septal defect occlude
Sponsors
West China Second Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 2-65 years (inclusive), gender is not limited. (2) Secondary perforated atrial septal defect (ASD) with diameter >= 5mm, right ventricular volume load increased, and left to right shunting ASD = 5 mm; Atrioventricular valve >= 7 mm. (4) No other cardiac malformations requiring surgery. (5) Volunteer to participate in the clinical trial, and sign the informed consent of the subjects.
Exclusion criteria
Exclusion criteria: (1) Primary pore type ASD and venous sinus type ASD. (2) Infectious endocarditis. (3) Complicated with severe myocardial disease or valvular disease unrelated to ASD. (4) Severe pulmonary hypertension leads to right-to-left shunt. (5) Thrombosis was found at the placement of the occluder (especially left atrium or left atrial appendage thrombosis), and venous thrombosis was found at the insertion of the catheter. (6) Have hemorrhagic disease or known coagulation dysfunction, or refuse blood transfusion. (7) Patients with structural heart disease other than ASD requiring treatment. (8) There are contraindications to antiplatelet therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of occlusion was 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate; | — |
Countries
China
Contacts
Public ContactYimin Hua
West China Second Hospital of Sichuan University
Outcome results
None listed