Ventricular septal deficiency
Conditions
Interventions
Group A:Fully degradable ventricular septal defect closure system
Group B:Ventricular septal defect occluder
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up; 2. Aged 1 to 60 years old, weight more than 10 kg, male or non-pregnant women; 3. VSD effective shunt =3mm, =14mm; 4. Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation.
Exclusion criteria
Exclusion criteria: 1. Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt; 2. Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions; 3. Sepsis or severe infection within 1 month prior to occlusion; 4. Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site; 5. Cardiac malformation dependent on ventricular septal defect (VSD); 6. Not suitable for treatment with this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blocking success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical technique success rate; | — |
Countries
China
Contacts
Public ContactXiangbin Pan
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed