Clinical Research Directory

Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with the symptoms of severe aortic stenosis 3. Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography 4. Patients deemed for cardiac intervention by a heart team 5. Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories. 6. Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements Exclusion Criteria: A subject meeting any of the following criteria shall be excluded: Co-morbidities 1. Previous mechanical or biological aortic valve replacement 2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention 3. Acute myocardial infact within 30 days prior to index procedure 4. Untreated clinical significant coronary artery disease requiring revascularization 5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months) 6. Sever symptomatic carotid artery stenosis 7. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability 8. Chronic kidney disease (eGFR\<30 mL/min/1.73m2) 9. Haemotologic disorders: Leukopenia (WBC \< 3000 cell/mL), anemia (Hgb \< 9 g/dL), thrombocytopenia (Plt\< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Haematooncology specialists 10. Severe right heart dysfunction Anatomical 11. LVEF \< 20% 12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation 13. Inappropriate anatomy for femoral introduction and delivery of study device 14. Native aortic valve geometry and size unfavorable for study device anchoring General 15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance 16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement 17. Life expectancy ≤ 1 year due to noncardiac reasons 18. Active infection requiring antibiotic therapy including infective endocarditis 19. Planned relevant concomitant procedure within 30 days post index procedure 20. Pregnant, breastfeeding or intend to become pregnant within 1 year