The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in
 subjects with severe, calcific AS who are at intermediate operative risk for standard aortic
 valve replacement.
Inclusion Criteria:

 1. 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

 2. New York Heart Association functional class ≥ II

 3. Judged by the Heart Team to be at intermediate risk for open surgical therapy

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

 Exclusion Criteria:

 1. Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis

 2. Aortic valve is unicuspid, bicuspid or non-calcified

 3. Pre-existing mechanical or bioprosthetic valve in any position.

 4. Severe aortic regurgitation (> 3+)

 5. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis

 6. Ventricular dysfunction with left ventricular ejection fraction < 30%

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

 8. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant
 procedure

 9. Subjects with planned concomitant ablation for atrial fibrillation

 10. Hypertrophic cardiomyopathy with obstruction

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

 12. Complex coronary artery disease:

 1. Unprotected left main coronary artery

 2. SYNTAX score > 32

 3. Heart Team assessment that optimal revascularization cannot be performed

 13. Iliofemoral vessel characteristics that would preclude safe placement of the
 introducer sheath

 14. Significant abdominal or thoracic aortic disease that would preclude safe passage of
 the delivery system

 15. Active bacterial endocarditis within 180 days of the valve implant procedure

 16. Stroke or transient ischemic attack within 90 days of the valve implant procedure

 17. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
 stenosis within 30 days of the valve implant procedure

 18. Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home
 oxygen

 19. Severe pulmonary hypertension

 20. Hemodynamic or respiratory instability requiring inotropic support, mechanical
 ventilation or mechanical heart assistance within 30 days of the valve implant
 procedure

 21. History of cirrhosis or any active liver disease

 22. Renal insufficiency and/or renal replacement therapy at the time of screening

 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or
 hypercoagulable states

 24. Inability to tolerate or condition precluding treatment with antithrombotic therapy
 during or after the valve implant procedure

 25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
 treated with pre-medication

 26. Significant frailty as determined by the Heart Team

 27. Subject refuses blood products

 28. Body mass index > 50 kg/m2

 29. Estimated life expectancy < 24 months

 30. Positive urine or serum pregnancy test in female subjects of childbearing potential

 31. Currently participating in an investigational drug or another device study.