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 < 30%
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
• Subjects with planned concomitant ablation for atrial fibrillation
• Hypertrophic cardiomyopathy with obstruction
• Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
• Complex coronary artery disease:

• Unprotected left main coronary artery
• SYNTAX score > 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% predicted) or currently on home oxygen
• Severe pulmonary hypertension
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
• History of cirrhosis or any active liver disease
• Renal insufficiency and/or renal replacement therapy at the time of screening
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
• Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
• Significant frailty as determined by the Heart Team
• Subject refuses blood products
• Body mass index > 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.