VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study

Who May Qualify: - 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 willing to sign a consent form and agreeing to the scheduled follow up requirement. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.