Clinical Research Directory

Inclusion Criteria: * Age≥70 years; * Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area\<0.8cm² (or EOA index\<0.5cm²/m²); * The patients considered to be not suitable for surgical aortic valve replacement (SAVR); * The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement. Exclusion Criteria: * Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； * Vascular diseases or anatomical condition preventing the device access； * Previous implantation of mechanical or bioprosthesis valve in the aortic position； * Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements； * Ongoing sepsis, including active endocarditis； * Estimated Life expectancy\< 12 months； * Participating in another trial and the primary endpoint is not achieved. * Inability to comply with the clinical investigation follow-up or other requirements.