Summary

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Age: 65 Years and older

Gender: All

Start Date: 10/12/2021

Primary Completion Date (Estimated): 06/01/2029

Study Completion Date (Estimated): 06/01/2037

Accepts Healthy Volunteers: No

Trial Purpose and Description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Eligibility Criteria

Age: 65 Years and older

Gender: All

Accepts Healthy Volunteers: No

Key inclusion criteria:

1. 65 years of age or older at time of randomization

2. Moderate aortic stenosis

3. Subject has symptoms or evidence of cardiac damage/dysfunction

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

Key exclusion criteria:

1. Native aortic annulus size unsuitable for the THV

2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system

3. Aortic valve is unicuspid or non-calcified

4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification

5. Pre-existing mechanical or bioprosthetic aortic valve

6. Severe aortic regurgitation

7. Prior balloon aortic valvuloplasty to treat severe AS

8. LVEF \< 20%

9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR

10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation

11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR