This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.
Male or Female
Age ≥ 65 years at time of consent
Women of non-childbearing potential
Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
Patient has a hypertrophic obstructive cardiomyopathy.
P+F Products + Features GmbH
Lead sponsor
Meditrial USA Inc.
Collaborator