Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis

Exclusion Criteria

• •General:
• •1. Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is \<16.5 mm or \>27 mm
• •2. Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported)
• •3. Significant disease of the aorta that would preclude safe advancement of the ALLEGRA THV System
• •4. Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible
• •5. Porcelain aorta
• •6. Severe left ventricular dysfunction with ejection fraction (EF) \<20% (site-reported)
• •7. Evidence of active endocarditis or other acute infections
• •8. Renal failure requiring continuous renal replacement therapy
• •9. Untreated clinically significant coronary artery disease requiring revascularization
• •10. Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure
• •11. Acute MI ≤30 days prior to the index procedure
• •12. Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
• •13. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score \>2)
• •14. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets \<80,000/µl), acute anemia (hemoglobin \<10 g/dl), leukopenia (WBC \<3000/ µl)
• •15. Active peptic ulcer or gastrointestinal (GI) bleeding ≤3 months
• •16. Severe (greater than 3+) mitral insufficiency (site-reported)
• •17. Uncontrolled atrial fibrillation
• •18. Required emergency surgery for any reason
• •19. Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
• •20. Life expectancy ≤12 months due to other medical illness
• •21. Currently participating in another investigational drug or device study
• •22. Pregnancy or intend to become pregnant during study participation
• •Specific exclusions in patients with native aortic valve disease (site-reported):
• •23. Unicuspid or bicuspid aortic valve
• •24. Non-calcified aortic stenosis
• •25. Predominant aortic regurgitation \> grade 3
• •26. Distance between native aortic valve basal plane and the orifice of the lowest coronary artery \<8 mm
• •Specific exclusions in patients with degenerated surgical bioprosthetic aortic valves (valve-in-valve) (site-reported):
• •27. Low position of the coronary ostia, especially in combination with shallow sinuses (high risk of coronary occlusion)
• •28. Partially detached leaflets that may obstruct a coronary ostium