The Leaflex™ Early Feasibility Study

Inclusion Criteria: * Patient with symptomatic, severe aortic stenosis who are operable, but not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. * Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent. Exclusion Criteria: * Inoperable for emergency surgery. * Moderate or greater aortic regurgitation. * Anatomic contraindications. * Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. * Aortic balloon valvuloplasty ≤ 3 months prior to index procedure. * Stroke ≤ 12 months prior to index procedure. * History of a myocardial infarction ≤ 6 weeks prior to index procedure. * Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. * Hemodynamic instability. * Hypertrophic cardiomyopathy with obstruction. * Left ventricle ejection fraction \<30%. * Ongoing severe infection, including endocarditis, or sepsis. * Life expectancy ≤ 12 months.