ventricular septal defect
Conditions
Interventions
1:Biodegradable VSD occluder and Delivery System
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Internal medicine: 1. perimembranous VSD: Age is usually >= 3 years old. Weight > 10kg. Hemodynamically simple VSD with a diameter between 3mm and14mm. The upper margin of VSD to the right aortic valve of the aorta is >=2 mm. There is no aortic right coronary artery detachment into VSD and aortic regurgitation. Echocardiogram shows the defect at the 9 to 12 o'clock position of the short-axis five-chamber view of the large vessel. 2. Muscular VSD>3mm. 3. Residual shunt after surgery. 4. Myocardial infarction or perforation of the interventricular septum after trauma. 5. Voluntarily participate in human clinical trials and sign informed consent to follow up as required. surgical: 1. perimembranous VSD: Age is usually >= 6 months. Weight > 5kg. Echocardiography suggests increased cardiac load, hemodynamical VSD with a diameter >= 3mm, for membranous tumor = 2 mm , no aortic right coronary artery detachment into VSD and aortic regurgitation. Echocardiogram shows the defect at the 9 to 12 o'clock position of the short-axis five-chamber view of the large vessel. 2. Muscular VSD > 3mm. 3. Patients having VSD combining with other malformations that require surgery, and can be treated by blocking the muscle VSD under heartbeat and then for other malformations. 4. Residual shunt after surgery. 5. Voluntarily participate in human clinical trials and sign informed consent to follow up as required.
Exclusion criteria
Exclusion criteria: 1. Infective endocarditis, sputum in the heart, or other infectious diseases. 2. There is a thrombus in the occluder placement, and there is venous thrombosis in the catheter insertion path. 3. Huge VSD, anatomical position of defect, and the occluder may affect the function of the aortic valve or atrioventricular valve after implantation. 4. Severe pulmonary hypertension combining with bidirectional shunt. 5. Combined with bleeding disorders and thrombocytopenia. 6. Combined with obvious liver and kidney dysfunction. 7. Incomplete heart function and intolerable operation. 8. Patient under pregnancy or breastfeeding, planning pregnancy, not agreeing to take effective contraceptive measures during the trial. 9. Investigator believes that patients who are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Closure success rate;Overall success rate;Complication rate; | — |
Countries
China
Contacts
Public ContactSun Kun
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed