Ostium secundum ASD patients
Conditions
Interventions
Case series:Implant Trial Device by Operation
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged =3 years, weight =10Kg; (2) Secundum left-to-right shunt ASD with hemodynamic significance; (3) Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein and AV valve should be =5mm;to atrioventricular valve=7mm; (4) The atrial septum length (stretched diameter) should be greater than the diameter of left disk.
Exclusion criteria
Exclusion criteria: (1) Patients of primum, venous sinus and coronary sinus ASD; (2) Patients with atrial septum defect =26mm; (3) Patients with other structural heart disease in addition to ASD; (4) Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome; (5) Infective endocarditis patients; (6) Patients with hemolysis or hemorrhagic disease, unhealed ulcer or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive six months) within one month before implantation; (7) Patients with thrombosis(especially in left atrium or left atrial thrombus) as shown by echocardiography; (8) Patients with known condition of hypercoagulation status; (9) Patients ever received heart operation; (10) Patients allergic to PLLA; (11) Patients refusing to sign the informed consent form; (12) Patients with poor compliance on treatment and poor cooperation on follow-up visits; (13) Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test result during the screening period; (14) Patients that have participated in any clinical trial that may affect the evaluation of the device in this trial and not completed or withdrawn from the previous clinical trial within 3 months prior to this trial screening period; (15) The patients considered to be not eligible for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective closure rate of the operation, up to 30±7 days after procedure;incidence rate of severe operative complications up to 360±30 days after procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Successful procedure rate of ASD;Device-related AE (adverse event) rates on the day following the procedure;Device-related SAE (serious adverse event) rates on the day following the procedure; | — |
Countries
China
Contacts
Public ContactZhang Zhiwei
Guangdong Provincial People's Hospital
Outcome results
None listed