Patients with ventricular septal defect
Conditions
Interventions
Group 1:Surgical patch (Beijing Puhui Biomedical Engineering Co., Ltd.)
Group 2:Surgical patch (Beijing Balance Medical Technology Co., Ltd)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
0.5 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 6 months and <= 60 years, no gender limit; 2. Diagnosed as ventricular septal defect (single), which can be combined with patent foramen ovale, pulmonary hypertension, or other valve regurgitation that does not require surgical treatment; 3. The patient or his guardian learns of the nature of the trial and agrees to participate in the trial, and voluntarily sign The informed consent form approved by the ethics committee agreed to accept the postoperative treatment plan and follow-up requirements. 4. The investigator judges patients who have at least one year of survival expectations.
Exclusion criteria
Exclusion criteria: 1. Eisen-menger syndrome and/or other heart malformations without indications for surgery; 2. Patients with infective endocarditis, bacteremia, sepsis, sepsis or fever of unknown origin; 3. Suffering diseases will cause difficulty in evaluation (such as malignant tumors, infections, severe metabolic diseases, mental illness, etc.); 4. Ventricular septal perforation caused by acute myocardial infarction; 5. Patients who need dialysis treatment. 6. Hematology: a. Hemoglobin (Hb) 12 x 10^9/L. c. Platelets (PLT) 34µmol/L (2mg/dL). 8. Those who have a history of cardiac or thoracic surgery within 30 days before surgery (except for those who have failed ventricular septal defect closure surgery); 9. Staged surgery patients or those planning to receive other structural heart surgery treatments within 6 months; 10. Patients who have a clear history of allergy to bovine pericardial materials and glutaraldehyde; 11. Patients who are pregnant, breastfeeding or planning to become pregnant within the next 5 years and cannot take effective contraceptive measures during the trial period (effective contraceptive measures include abstinence, sterilization, intrauterine device, oral or other hormonal contraceptives, or local laws The prescribed diaphragm method) male or female of childbearing age; 12. Patients who have participated in but have not completed other clinical trials; 13. The researcher judges that patients have poor compliance and cannot complete the study as required (including but not limited to patients with obvious mental disorders, epilepsy and other incapacitated or cognitive abilities); 14. The investigator judges that it is not suitable for ventricular septal defect patch repair surgery; 15. Social aid workers and non-Chinese citizens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No device-related serious adverse event rate within 30 days after surgery;Complete closure rate of ventricular septal defect 6 months after surgery; | — |
Countries
China
Contacts
Public ContactQi an
West China Hospital of Sichuan University
Outcome results
None listed