Atrial Septal Defect
Conditions
Interventions
Echo group:Echocardiography guided closure
Fluoro group:fluoroscopy guided closure
Sponsors
Fuwai Hospital Chinese Academy of Medical Science, Shenzhen
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 2 years; 2. Diagnosed as secundum ASD, ASD diameter >= 6mm, = 5mm; to valve >= 7mm.
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. Allegy to contrast agent; 3. Renal insufficiency (eGFR < 45mL/min/1.73m²); 4. Presence of other cardiac malformations requiring surgical intervention.; 5. Presence of any other right-to-left shunt pathologies.; 6. Defects of septum primum, sinus venosus defects; 7. Any severe infection 1 month prior surgery; 8. Intra-cardiac thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be procedure success rate evaluated 1 day post-procedure by transthoracic echocardiography, defined as proper device placement without converting to surgery or any other form of interventional procedure and without residual shunt >2mm or occuluder migration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complication rate within 3 months;In-hospital complication rate;Total hospital revenue at discharge and hospitalization costs excluding the occluder device cost;Length of hospital stay;Length of procedure;Hospital costs, defined as the costs of the hospital where the ASD surgery is performed for the patient, include costs for surgical facilities, surgical equipment, surgical personnel, etc.;Radiation dose and duration;Success rate of occlusion at 3 months postoperation; | — |
Countries
China
Contacts
Public ContactZhang Jing
Fuwai Hospital Chinese Academy of Medical Sciences
Outcome results
None listed