Pulmonary regurgitation or stenosis after correction of congenital heart disease
Conditions
Interventions
Single Arm:Surgical intervention
Sponsors
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Inclusion criteria
Inclusion criteria: The subject enrolled in the trial shall meet the following conditions 1. Age > 10 years old or body weight > 25kg, and; 2. Patients with NYHA Class II or above shall meet (1); patients with NYHA Class I shall meet (1) and (2). (1) Patients with NYHA Class II or above shall meet one of the following: a. Regurgitation score measured by cardiac MRI > 30%; b. Transthoratic echo (TTE) indicates moderate (3+) or severe (4+) pulmonary regurgitation. (2) Patients with NYHA Class I shall also meet one of the following: a. Right ventricle end diastole volume index (RVEDVI) measured by cardiac MRI > 150ml/m2 b. The ratio of right ventricle end diastole volume (RVEDV) to left ventricle end diastole volume (LVEDV) > 2.0, as measured by cardiac MRI.
Exclusion criteria
Exclusion criteria: Patients with any one of the following conditions shall not participate in the trial: 1) If the patient's anatomy precludes the introduction of the TPV, including that the vessel cannot accommodate the delivery system or the RVOT-PA cannot accommodate the TPV, and that there pre-procedural examination indicates a potential of compression of the coronary artery; 2) Pulmonary hypertension > 30mmHg measured by diagnostic catheter; 3) Acute decompensated heart failure; 4) History of infectious endocarditis, or active infectious endocarditis; 5) Known allergy to aspirin or heparin; 6) Other conditions or diseases that may significantly shorten the lifespan of the patients, such as malignant tumor, severely compromised liver and renal function, acute coronary syndrom, or requiring other surgeries at the same time or in the near future; 7) Female patients of reproductive age test positive in urine or blood pregnancy test; 8) Currently participating in another clinical trial; 9) Patients or their legal guardian are unwilling to provide signed informed consent or to follow the trial plan; 10) Considered by the investigator to be unsuitable for the implantation of TPV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of functional valve;success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary regurgitation score measured by echo;Pressure gradient across the pulmonary valve measured by echo;Pulmonary regurgitation score measured by MRI;RVEDV, RV-EDVI, RV-EF;NYHA heart function class;Incidence of surgical or device related death;Incidence of surgical or device related serious adverse events;Incidence of adverse events;The incidence of valve removal or re intervention; | — |
Countries
China
Contacts
Public ContactDong Nianguo
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed