Clinical Research Directory

Inclusion Criteria: * Symptomatic Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2) * Males or females of at least 18 years of age * Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team * Signed informed consent * TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience) Exclusion Criteria: * Transapical TAVI * Preexisting aortic prosthesis (valve in valve technique) * Vascular conditions that make insertion and endovascular access to the aortic valve impossible * BAV performed for less than one week * Recent myocardial infarction (STEMI within the last 3 months) * Left ventricular or atrial thrombus by echocardiography * Mitral or tricuspidal valvular insufficiency (\> grade II) * Evolutive or recent cerebrovascular event (within the last 3 months) * Symptomatic carotid or vertebral arterial narrowing (\>70%) disease * Bleeding diathesis or coagulopathy or patient refusing blood transfusion * Lack of written informed consent, severe mental disorder, drug/alcohol addiction * Life expectancy \< 1 year * Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media that cannot be adequately premedicated * Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study. * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Pregnancy