Ventricular septal defect
Conditions
Interventions
Group A:nano membrane single riveted ventricular septal defect (VSD) occluder
Group B:ventricular septal defect (VSD) occluder
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 1 to 60 years old, weight more than 5 kg, male or non-pregnant women; 2. Membranous ventricular septal defect with hemodynamic abnormalities or increased left ventricular diamete 3. The narrowest part of ventricular septal defect (VSD) 3mm to 12mm; 4. The upper margin of the ventricular septal defect is >=2mm from the right aortic valve and >=2mm from the tricuspid septal valve. There is no aortic right coronary valve detachment into the ventricular septal defect and aortic valve reflux; 5. Ultrasound at 9-12 o'clock on the short-axis five-chamber view of the large vessel; 6. Understand the purpose of the trial, volunteer to participate in the trial and sign the "Informed Consent form". 7. The patient is willing to carry out regular follow-up evaluation.
Exclusion criteria
Exclusion criteria: 1. Irreversible pulmonary vascular disease;Patients with severe pulmonary hypertension leading to right-to-left 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 |
|---|---|
| technique success rate; | — |
Countries
China
Contacts
Public ContactShengshou Hu
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed