aortic stenosis
Conditions
Interventions
TAVI group:TAVI
SAVR group:SAVR
Sponsors
Tianjin Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New York Heart Association [NYHA] class II function or worse; 2. Severe aortic stenosis was defined as an aortic-valve area of less than 0.8 cm2 (or AVA index of less than 0.5 cm2/m2) plus either a mean valve gradient of at least 40 mm Hg or a peak velocity of at least 4.0 m per second; 3. STS(Society of Thoracic Surgeons)risk model of at least 8%.
Exclusion criteria
Exclusion criteria: 1. a bicuspid valve; 2. severe coronary artery disease requiring revascularization or evidence of acute myocardial infarction within one month(Q-wave myocardial infarction,or non-Q-wave myocardial infarction,with CK-MB of at least twice normal or Tn increased); 3. a left ventricular ejection fraction of less than 20%; 4. severe mitral or aortic regurgitation; 5. an aortic annulus diameter of less than 20 mm or more than 32 mm; 6. a recent cerebral embolism; 7. renal failure(calculated creatinine clearance of less than 20 ml/min); 8. hemorrhagic habitus or coagulation disorders,septicemia; 9. life expectancy of less than 1 year; 10. uncontrolled atrial or ventricular arrhythmia; 11. be allergic to anticoagulant,nickel metal or contrast medium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| death;re-admission;stroke; | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA functional class;acute myocardial infraction;acute renal failure;bleeding;third degree atrioventricular block; | — |
Countries
China
Contacts
Public ContactNan Jiang
Tianjin Chest Hospital
Outcome results
None listed