Aortic stenosis
Conditions
Interventions
Experimental group:Operation treatment
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 60 years; 2. There are symptoms of severe aortic stenosis; 3. Severe aortic stenosis (native aortic valve); 4. The diameter of the native aortic valve annulus measured by CT should be 20mm-23mm; 5. The subject or the legal representative of the subject knows the nature of the study and agrees to participate in all terms of the study, and signs the informed consent form approved by the ethics committee of each clinical center; 6. Subject agrees to all follow-up visits after surgery.
Exclusion criteria
Exclusion criteria: 1. There is a known allergic reaction or contraindication to any of the following: (1) Heparin (HIT/HITTS); (2) Nickel, titanium and/or PTFE polymeric materials; 2. Hematological abnormalities, defined as: leukopenia (WBC 22 and multivessel coronary artery disease without protection of left main trunk; 5. Acute myocardial infarction within 30 days before surgery; 6. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; 7. End-stage renal disease (endogenous creatinine clearance less than 30ml/min or long-term dialysis treatment required) or after kidney transplantation; 8. Persistent sepsis, including active endocarditis; 9. History of cardiac surgery or interventional surgery within 30 days before surgery; 10. Severe carotid or vertebral artery stenosis requiring surgical intervention, or within 3 months after stenosis treatment; 11. Cardiogenic shock or low cardiac output syndrome, need to rely on vasoactive substances or mechanical circulation to maintain hemodynamic stability; 12. Cerebrovascular accident or transient ischemic attack (TIA) within 6 months before surgery; 13. Active peptic ulcer or gastrointestinal bleeding within 3 months before surgery; 14. The subject refuses blood transfusion; 15. Inability to comply with the study protocol or complete follow-up; 16. Life expectancy <12 months due to non-cardiac reasons; 17. Currently participating in other drug or device research; 18. Subjects who need emergency surgery for any reason; 19. Severe hepatic insufficiency (Child-Pugh class C); 20. Other circumstances that the researcher deems inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 days postoperative all-cause mortality; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital of Sichuan University
Outcome results
None listed