Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Inclusion criteria:

1. Male or Female

2. Age ≥ 65 years at time of consent

3. Women of non-childbearing potential

4. Severe degenerative calcific native aortic valve stenosis with the followingcriteria assessed either by resting or dobutamine stress TTE:

5. Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and

6. Jet velocity > 4.0 m/s or mean gradient > 40 mmHg

7. Symptomatic aortic stenosis (AS), defined as a history of at least one of thefollowing:

8. Dyspnea that qualifies at NYHA class II or greater

9. Angina pectoris

10. Cardiac syncope

11. Subject is considered at intermediate or high risk for surgical valve replacementbased on at least one of the following:

12. EuroSCORE II ≥ 4% along with assessment of frailty, major organ systemdysfunction, and procedure-specific impediments, in accordance with scientificguidelines

13. Agreement by the Heart Team that subject is at moderate to high operative riskof serious morbidity or mortality with surgical valve replacement.

14. The local Heart Team deems the patient to be eligible for transfemoral TAVI.

15. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured bycomputed tomography (CT) analyzed by a core lab.

16. Adequate iliofemoral access with either:

17. At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level ofvessel calcification and tortuosity for safe placement of the introducersheath, as analyzed by a core lab, OR

18. At least one side with minimum vessel diameter ≥ 5.5 and no significantcalcification or severe tortuosity for safe placement of the introducer sheath,as analyzed by a core lab.

19. Patient (or legal representative) understands the study requirements and thetreatment procedures and provides written informed consent.

20. The patient and the treating physician agree that the patient will return for allrequired post-procedure follow-up visits.

Exclusion Criteria:

Cardiovascular System:

1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.

2. Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMDimplantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twicenormal in the presence of CK-MB elevation and/or troponin elevation).

3. Patient has had a cerebrovascular stroke or TIA within the past 90 days implantationprior to screening or valve implantation.

4. Patient has a hypertrophic obstructive cardiomyopathy.

5. History of any therapeutic invasive cardiac procedure (including balloon aorticvalvuloplasty) within 30 days prior to screening or IMD implantation (except forpacemaker implantation which is allowed).

6. Untreated clinically significant coronary artery disease requiring revascularizationat the screening visit.

7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclideventriculography.

8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamicinstability and vasopressor dependence, or mechanical hemodynamic support

9. Patients with clinically significant conduction abnormalities (clinicallysignificant sinus bradycardia, sinus block or pauses, clinically significantatrioventricular (AV)-block >I) at screening and at time of IMD implantation.

10. Patient has severe peripheral vascular disease:

11. including aortic aneurysm defined as maximal luminal diameter > 5 cm or withdocumented presence of thrombus, marked tortuosity, narrowing of the abdominalaorta, severe unfolding of the thoracic aorta or thick [> 5 mm], protruding orulcerated atheroma in the aortic arch) or

12. symptomatic carotid or vertebral disease or successful treatment of carotidstenosis within 30 days prior to screening or IMD implantation.

13. Patient with iliofemoral vessel characteristics that would preclude safe passage ofthe introducer (both sides), as analyzed by a core lab:

14. severe calcification,

15. severe tortuosity (> two 90-degree bends),

16. diameter < 6 mm, in patients with acceptable levels of calcification andacceptable levels of tortuosity

17. diameter < 5.5, in patients with no calcification and no significanttortuosity, OR

18. subject has had an aorto-femoral bypass

19. Patient with active bacterial endocarditis within 6 months prior to screening or IMDimplantation.

20. Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass,thrombus or vegetation.

21. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ringis not an exclusion).

22. Patient has severe mitral regurgitation, severe aortic regurgitation or severetricuspid regurgitation, moderate or severe mitral stenosis.

23. Patient has a need for emergency surgery for any reason at time of screening or IMDimplantation. General:

24. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)

25. Patient with renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula)and/ or renal replacement therapy and/ or has serum creatinine level > 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening

26. Patient with significant pulmonary disease (FEV1 < 30%) or currently on home oxygen

27. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)

28. Patients with evidence of an active systemic infection or sepsis.

29. Patient has a known hypersensitivity or contraindication to contrast media, bovinetissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.

30. Patient has a haemoglobin < 9 g/dL, platelet count < 50,000 cells/mm3 or > 700.000cells/mm3, or white blood cell count < 1.000 cells/mm3, history of bleedingdiathesis or coagulopathy

31. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.

32. Patient refuses blood transfusions.

33. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbidconditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).

34. Patient is pregnant or breast feeding.

35. Severe dementia (resulting in either inability to provide informed consent for thestudy/procedure, prevents independent lifestyle outside of a chronic care facility,or will fundamentally complicate rehabilitation from the procedure or compliancewith follow-up visits).

36. Other medical, social, or psychological conditions that in the opinion of theInvestigator precludes the patient from appropriate consent or adherence to theprotocol required follow-up exams.

37. Patient is currently participating in another investigational drug or device studythat has not reached its primary endpoint (excluding observational studies).