The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
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.
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；
The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team
Cohort
Prospective
VitaFlow™ Transcatheter Aortic Valve System
DeviceVitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
Rate of all-cause mortality at 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Valve function-mean transvalvular gradient
Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Valve function-effective orifice area
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2)
Valve function-degree of prosthetic valve regurgitation
Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Rate of safety events according to VARC2
Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation
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