Pulmonary valve regurgitation
Conditions
Interventions
Experimental group:Fresh allogeneic valve replacement surgery
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 10 Years
Inclusion criteria
Inclusion criteria: 1. Age: Under 10 years old. (2) Congenital heart diseases that require right ventricular outflow tract reconstruction and valve replacement after a definite diagnosis. The right ventricular end - diastolic volume (RVEDV) measured by preoperative magnetic resonance imaging is greater than 160 mL/m^². (3) The legal guardian signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Absolute contraindications for cardiopulmonary bypass/surgery. (2) Severe bilateral long - segment pulmonary artery hypoplasia. (3) Bilateral pulmonary vein stenosis. (4) Suffering from immunodeficiency. (5) Infectious diseases, positive for hepatitis B surface antigen or HIV. (6) Active infection. (7) Severe cognitive/mental disorders in parents (guardians) to the extent that they are unable to understand the medical plan and complete the follow - up as scheduled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation within 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Valve growth capacity;Immunosuppression-related adverse events;Re - intervention rate;Valve function assessment; | — |
Countries
China
Contacts
Public ContactZhanghao
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed