The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

Inclusion Criteria

• Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
• Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2
• Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
• New York Heart Association functional class ≥ II
• Judged by the Heart Team to be at intermediate risk for open surgical therapy
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

• Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
• Aortic valve is unicuspid, bicuspid or non-calcified
• Pre-existing mechanical or bioprosthetic valve in any position.
• Severe aortic regurgitation (> 3+)
• Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
• Ventricular dysfunction with left ventricular ejection fraction 32
• Heart Team assessment that optimal revascularization cannot be performed
• Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath
• Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
• Active bacterial endocarditis within 180 days of the valve implant procedure
• Stroke or transient ischemic attack within 90 days of the valve implant procedure
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
• Severe lung disease (Forced Ejection Volume 1 50 kg/m2
• Estimated life expectancy < 24 months
• Positive urine or serum pregnancy test in female subjects of childbearing potential
• Currently participating in an investigational drug or another device study.