TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

Inclusion Criteria: * Symptomatic Aortic valve stenosis with an aortic valve area \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