Aortic Valve stenosis
Conditions
Interventions
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 70 years and more; 2. Moderate or severe aortic stenosis, moderate or high risk on STS score; 3. NHYA grade=II; 4. The life expectancy of more than 12 months; 5. The anatomy suitabe for transcatheter aortic valve implantation surgery; 6. The patient can understand the purpose of the experiment, voluntary and signed informed consent, willing to accept the relevant examination and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction occurred within 30 days or had received any treatment for cardiac surgery; 2. Congenital unicuspid aortic valve disease, aortic annulus diameter or too large or too small, or aortic root anatomy inappropriate for valve implants; 3. Combined with other surgical treatment of valvular disease, such as severe aortic valve insufficiency, moderate and severe mitral stenosis, severe mitral regurgitation, severe three valve regurgitation; 4. The blood system of cachexia, including neutropenia (WBC < 3 * 10^9/L), acute anemia (HB < 90g/L), thrombocytopenia (PLT < 50 * 10^9/L), bleeding and coagulation disorders disease constitution; 5. Any need for emergency operation; 6. Severe heart and kidney dysfunction, left ventricular ejection fraction (LVEF) < 20%; pulmonary hypertension and right ventricular dysfunction; renal insufficiency decompensation (creatinine clearance < 20ml/min), and / or ESRD needs long-term dialysis treatment; 7. Echocardiography demonstrated heart mass, thrombosis or neoplasm, or a combination of active infective endocarditis or other active infection; 8. The active stage of peptic ulcer or within 3 months of upper digestive tract hemorrhage, occurred within 6 months of cerebrovascular events, including transient ischemic attack (TIA); 9. Allergic to aspirin, heparin, ticlopidine, Grey, nickel titanium alloy or contrast agent; 10. The patients join other drugs or medical devices clinical trials, poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| success rate;Incidence of myocardial infarction;Incidence of severe stroke;Incidence of severe bleeding;Rate of acute renal injury; | — |
Countries
China
Contacts
Public ContactQu Xinkai
Shanghai Chest Hospital
Outcome results
None listed