Clinical Research Directory

Inclusion Criteria: * Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation. * Patient has senile degenerative aortic valve stenosis * Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months. * Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT. Exclusion Criteria: * Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure. * Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve. * Patient has severe aortic valve regurgitation. * Patient has severe mitral valve regurgitation. * Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary. * Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.