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

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 IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal 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 implantation prior to screening or valve implantation.
• •4. Patient has a hypertrophic obstructive cardiomyopathy.
• •5. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
• •6. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
• •7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
• •8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
• •9. Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \>I) at screening and at time of IMD implantation.
• •10. Patient has severe peripheral vascular disease:
• •1. including aortic aneurysm defined as maximal luminal diameter \> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick \[\> 5 mm\], protruding or ulcerated atheroma in the aortic arch) or
• •2. symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
• •11. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:
• •1. severe calcification,
• •2. severe tortuosity (\> two 90-degree bends),
• •3. diameter \< 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity
• •4. diameter \< 5.5, in patients with no calcification and no significant tortuosity, OR
• •5. subject has had an aorto-femoral bypass
• •12. Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.
• •13. Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
• •14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
• •15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
• •16. Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.
• •General:
• •17. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
• •18. 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
• •19. Patient with significant pulmonary disease (FEV1 \< 30%) or currently on home oxygen
• •20. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)
• •21. Patients with evidence of an active systemic infection or sepsis.
• •22. Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.
• •23. Patient has a haemoglobin \< 9 g/dL, platelet count \< 50,000 cells/mm3 or \> 700.000 cells/mm3, or white blood cell count \< 1.000 cells/mm3, history of bleeding diathesis or coagulopathy
• •24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.
• •25. Patient refuses blood transfusions.
• •26. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).
• •27. Patient is pregnant or breast feeding.
• •28. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
• •29. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.
• •30. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).