Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Inclusion criteria

• . Age ≥ 65 years ;
• . Autologous degenerative aortic stenosis（evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg , or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm2, or AVA \<0.5cm2 /m2）
• . Patients with aortic annulus size≥17.5mm and ≤29mm (echocardiography measurement);
• . The diameter of the ascending aorta of the patient was \< 45mm.
• . Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ to IV;
• . Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• . Subjects are willing to accept all clinical follow-up.
• . The cardiologist and cardiac surgeon evaluated the subject as unsuitable for surgical treatment (the risk of death or irreversible complications within 30 days after operation is expected to be above 50% , or contraindicated comorbidities such as prior chest radiotherapy, liver failure, diffuse severe calcification of the aorta, extreme weakness, etc.). Or Moderate or higher surgical risk (STS score ≥ 4%).

Exclusion criteria