China S3 PMS: SAPIEN 3 China Post Market Registry Study

Inclusion Criteria:

1. Patient with symptomatic, severe, calcified aortic stenosis who is appropriate forthe treatment with transcatheter aortic valve replacement as determined by a heartteam and will undergo TAVI with the Edwards SAPIEN 3 System as part ofstandard-of-care treatment

2. All surgical risks as determined by the site Heart Team

3. The subject or subject's legal representative has been informed of the nature of thestudy, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Medical, social, or psychological conditions that preclude appropriate consent andfollow-up, including subjects under guardianship

2. Considered to be part of a vulnerable population

3. Pre-existing mechanical or bioprosthetic aortic valve

4. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae thatcould confound endpoint assessments

5. Cannot tolerate an anticoagulation/antiplatelet regimen

6. Evidence of intracardiac mass, thrombus, vegetation, active infection orendocarditis

7. Tortuous or calcified vessels that would prevent safe entry of the dilators andsheath

8. Participating in a drug or device study that has not reached its primary endpoint