Die BIOVALVE klinische Studie. Das Prüfprodukt ist die BIOVALVE Aortenklappen-Prothese ("BIOVALVE Prothese"). In dieser klinischen Studie wird die Sicherheit und klinischen Leistungsfähigkeit der BIOVALVE Prothese in Patienten mit schwerer, symptomatisch kalzifizierter Aortenklappenstenose untersucht.

Device: BIOVALVE prosthesis

Inclusion Criteria:

1. The subject is =65 years

2. The subject has provided written informed consent

3. Subject is willing to participate in the clinical investigation and to comply with all
of the study procedures and follow-up visits

4. NHYA class =II

5. High surgical risk: Logistic EuroSCORE-I =20% (or equivalence of EuroSCORE-II) or STS
score =10% or co-morbidity judged by the heart team (consisting of at least one
interventional cardiologist and one cardiac surgeon) to pose an absolute or relative
contraindication for conventional aortic valve replacement according to VARC-2

6. Severe symptomatic calcific aortic valve stenosis characterized by mean aortic
gradient >40 mm Hg or peak jet velocity >4.0 m/s or effective orifice area (EOA) of
<1.0 cm2 (<0.6 cm2/m2 body surface area)

7. Annulus diameter as determined by multi-slice computed tomography (MSCT) from 23-26 mm

Exclusion Criteria:

1. Trans-esophageal echocardiogram (TEE) is contraindicated

2. Congenital bicuspid or unicuspid valve

3. Left ventricular outflow tract (LVOT) obstruction such as hypertrophic obstructive
cardio myopathy (HOCM) or subject presenting with systolic anterior motion (SAM).
Evidence of intra cardiac mass, thrombus or vegetation

4. Transfemoral access vessel characteristics that would preclude safe placement of a 18
French sheath

5. Vessel and/or anatomical characteristics that would preclude safe delivery of the
BIOVALVE prosthesis to the ascending aorta and/or placement of the prosthesis

6. Anatomical restrictions such as shallow sinuses with heavily calcified leaflets, low
height of coronary ostia, extreme tortuosity of the aortic arch, thoracic (TAA) or
abdominal (AAA) aortic aneurysm, presence of endovascular stent graft

7. Severe mitral regurgitation grade >3

8. Severe mitral stenosis

9. Prosthetic mitral valve

10. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF)
<20%

11. Hemodynamic instability

12. Percutaneous coronary intervention (PCI) within 30 days prior to index procedure and /
or planned PCI during index procedure

13. Renal insufficiency (creatinine >2.5 mg/dl) or subject under dialysis and/or renal
replacement therapy

14. Any cerebrovascular event or transient ischemic attack (TIA) within 180 days prior to
TAVI procedure

15. Evidence of acute myocardial infarction (defined as =2 fold CK level or in absence of
CK a =3 fold CKMB level above the upper range limit within =30 days prior to TAVI
procedure)

16. Blood dyscrasia defined as: leucopenia (WBC <1000 mm³), thrombocytopenia (platelet
count <50'000 cells/mm³), history of bleeding diathesis requiring blood transfusion

17. Ongoing sepsis or suspected active endocarditis

18. Active peptic ulcer or gastrointestinal bleeding within last 3 months that would
preclude anticoagulation

19. Subject refuses blood transfusion

20. Known hypersensitivity to, or contraindication to nitinol,
anticoagulation/antiplatelet regimes, any other medications required for the procedure
or post-procedure as determined by the heart team, or sensitivity to contrast media
which cannot be adequately pre-medicated

21. Need for emergency TAVI intervention, or other medical, social, or psychological
conditions that in the opinion of the heart team precludes the subjects from
appropriate consent or adherence to protocol required follow-up exams

22. Expectation that subject will not improve despite treatment of aortic stenosis

23. Estimated life expectancy of less than 12 months due to associated non-cardiac
co-morbidities

24. Severe pulmonary hypertension (> 60 mm Hg assessed by continuous wave Doppler, TTE) or
clinical signs of acute severe right ventricular dysfunction

25. Currently participating in another investigational drug or device study where primary
endpoint has not been reached yet