Alwide Plus China Post-market Clinical Investigation

Exclusion Criteria

• •Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure
• •TAVR procedure in trans-apical access
• •Pre-implanted mechanical or bioprosthetic valve at the aortic valve position
• •Acute myocardial infarction (MI) occurred in the last 30 days before the treatment；
• •LVOT obstruction;
• •Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%
• •Echocardiographic evidence of intracardiac mass, thrombus or neoplasm；
• •Unable to receive anticoagulation or antiplatelet therapy；
• •Allergy to nitinol or sensitive contrast media；
• •Active bacterial endocarditis or other active infection may affect the procedure；
• •Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team；
• •Life expectancy \> 12 months；
• •vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease；
• •Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached；
• •Investigators determined that patients have poor compliance and can't complete the study as required