The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

Prospective, randomized, controlled, multi-center trial. Patients having an operative
mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized
1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3
or aortic valve replacement with a commercially available surgical bioprosthetic valve.
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually
through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional
patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations
Registry (UPR) or the Alternative Access Registry.

Inclusion Criteria:

1. No age restriction.

2. Severe, calcific aortic stenosis.

3. Heart team agrees the patient has a risk of operative mortality and has an STS <4.

4. The study patient has been informed of the nature of the study, agrees to its
provisions and has provided written informed consent as approved by the Institutional
Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

1. Ilio-femoral vessel characteristics that would preclude safe placement of the
introducer sheath.

2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.

3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
non-calcified.

4. Severe aortic regurgitation (>3+).

5. Severe mitral regurgitation (>3+).