Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study

Inclusion Criteria: 1. Severe symptomatic calcific aortic valve stenosis with: 1. High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients), 2. High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150). 3. Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score \> 4 or EuroSCORE ≥ 10). 2. Age ≥ 75 years 3. NYHA ≥ II 4. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate. 5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits. Exclusion Criteria: 1. Non-calcified aortic valve 2. Acute myocardial infarction ≤ 30 days before the intended treatment 3. Untreated clinically significant coronary artery disease requiring revascularization. 4. Aortic valve is a congenital unicuspid or congenital bicuspid valve. 5. Mixed aortic valve disease (with predominant aortic regurgitation) 6. Preexisting bioprosthetic valve or ring in any position 7. For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).