Reprioritization of attention and resources by Sponsor.

A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.

A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.

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.