Tetralogy of Fallot
Conditions
Interventions
surgical group:pulmonary valve replacement
drug treatment group:conservational drug treatment
Sponsors
Fuwai Hospital, Chinses Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Asymptomatic patients with =2 of the following criteria: (1) RV end-diastolic volume index >150 mL/m2 or z score >4. In patients whose body surface area falls outside published normal data: RV/LV end-diastolic volume ratio >2 (2) RV end-systolic volume index >80 mL/m2 (3) RV ejection fraction 160 ms (7) Sustained tachyarrhythmia related to right-sided heart volume load; (8) Other hemodynamically significant abnormalities: RVOT obstruction with RV systolic pressure =0.7 systemic; Severe branch pulmonary artery stenosis (<30% flow to affected lung) not amenable to transcatheter therapy; Greater than or equal to moderate tricuspid regurgitation; Left-to-right shunt from residual atrial or ventricular septal defects with pulmonary-to-systemic flow ratio =1.5; Severe aortic regurgitation. 2. Symptomatic patients fulfilling =1 of the quantitative criteria detailed above. Examples of symptoms and signs include: (1) Exercise intolerance not explained by extracardiac causes (eg, lung disease, musculoskeletal anomalies, genetic anomalies, obesity), with documentation by exercise testing with metabolic cart (=70% predicted peak GraphicO2 for age and sex not explained by chronotropic incompetence); (2) Signs and symptoms of heart failure (eg, dyspnea with mild effort or at rest not explained by extracardiac causes, peripheral edema); (3) Syncope attributable to arrhythmia.
Exclusion criteria
Exclusion criteria: Those with one of the following criterias will be excluded from stuty: 1. those with obvious symptoms like right heart insufficinece, syncope caused by arrthymia, 2. severe right ventricle outflow tract obstruction () 3. RVP 4. severe arrhythmia or ICD-inserted; 5. history of pulmonary valve replacement; 6. contraindicated to MRI; 7. incapable to accept the cardiopulmonary exercise; 8. surgery contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the postoperative ejection fraction value of right heart mneasured by MRI after 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| PR;RVEDVi;RVESVi;MOC;MOP; | — |
Countries
China
Contacts
Public ContactShoujun Li
Fuwai Hospital, Chinses Academy of Medical Sciences
Outcome results
None listed