severe aortic stenosis
Conditions
Interventions
experimental group:Transcatheter aortic valve implantation system
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years; 2. Severe aortic stenosis [1]: echocardiography shows a transaortic valve blood flow velocity >= 4 m/s, or a mean transaortic valve pressure gradient >= 40 mmHg (1 mmHg = 0.133 kPa), or an aortic valve orifice area = II; 4. The aortic root and access anatomy meet the requirements for TAVR; 5. Expected postoperative survival > 1 year; 6. Patients assessed by the heart team as unsuitable for conventional surgical procedures: a mortality risk or incidence of irreversible complications > 50% within 30 days; or patients with moderate to severe frailty (>= 2 frailty indicators); or patients with more than 3 severe irreversible organ damages, such as lung disease, liver disease, kidney disease, etc.; or other factors affecting surgical procedures, such as chest radiotherapy, thoracic deformity, diffuse severe aortic calcification, etc.; 7. Willing to participate and sign the informed consent form, with sufficient compliance with the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1. Thrombus in the left ventricle, or severe obstruction of the left ventricular outflow tract; 2. Acute myocardial infarction within 30 days or severe coronary artery stenosis requiring surgical intervention; 3. Combined with severe mitral stenosis, severe mitral regurgitation, and severe tricuspid regurgitation (excluding secondary/functional tricuspid regurgitation); 4. The investigator determines that the femoral artery approach is unsuitable for TAVI; 5. Aortic annulus diameter 30mm; 6. Severe left ventricular dysfunction, ejection fraction < 20%; 7. Cerebrovascular accident (CVA) within the past 3 months; 8. Active endocarditis or other active infections; 9. Severe liver dysfunction (Child-Pugh class C, see Appendix 3 for details); 10. Active upper gastrointestinal ulcer, bleeding, or severe coagulation disorder, or known contraindication or allergy to all anticoagulation regimens, or inability to use anticoagulants in the trial; 11. Subjects known to be allergic to nickel-titanium alloy; 12. Currently participating in a medical device study that has not yet completed the primary endpoint or would clinically interfere with the endpoints of this study; 13. Subjects with poor compliance or subjects deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| operation success rate;Device Success rate;Device operating performance evaluation;Performance evaluation of implanted valves;Postoperative NYHA cardiac function class;Postoperative quality of life evaluation;mortality;Incidence of major adverse events; | — |
Countries
China
Contacts
Public ContactNianguo Dong
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed