Ventricular Septal Defect
Conditions
Interventions
Experimental group:Surgical repair ,Use Biological Patch of trial group
Control Group:Surgical repair,Use Biological Patch of control group
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
0.5 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patient aged 6 months to 60 years; 2. The patient diagnosed with VSD(?Isolated single ),or VSD with Patent Foramen OvalePulmonary Hypertensionor VSD combined with Valve Regurgitation that without operation requirement; 3. The patient or his guardian is able to provide informed consent based on local requirements, and has provided written informed consent as approved by the Ethics Committee of the respective clinical siteThe patient agrees to return the clinic trial site for all required post-procedure follow-up visits; 4. The patient has a life expectancy more than 1 year.
Exclusion criteria
Exclusion criteria: 1. Eisen-menger or/and cardiac anomaly without surgical requirement; 2. Active endocarditisbacteremia, septicemia, sepsisand fever of unknown origin; 3. Suffering from the disease which will cause evaluation difficulties such as CancersInfectious diseasesSerious metabolic diseasespsychoses, etc.; 4. Ventricular septal perforation secondary to acute myocardial infarction; 5. Patients with kidney failure who required chronic dialysis; 6. Hematological abnormality: (1) Hb12x109/L; (3) PLT=2.5 ULN; STB>34umol/L (2mg/dL); 8. Patients with Cardiac or thoracic surgeries within prior 30 days to enrollment (Excluding VSD transcatheter closure); 9. Patients planned staging operation or other cardiac surgeries within 6 months; 10. Patients allergied to device's components, bovine pericardiumglutaraldehyde; 11. Pregnant or lactating female or males and females in pregnancy preparation within 5 years; 12. Patients had participated in another clinical trial but didn't completed; 13. Patients'compliance to follow-up visits was low in the judgment of the investigator,or unable to complete the follow-up visits as required(Including but not limited to patients with significant psychiatric?morbiditiesepilepsy and other persons without behavioral or cognitive abilities); 14. Exceptional cases are unsuitable for VSD surgeries in the judgment of the investigator; 15. Social assistance personnel and Non-Chinese citizens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Doppler?Echocardiography;Electrocardiogram; | — |
Contacts
Public ContactAn Qi
West China Hospital, Sichuan University
Outcome results
None listed