Optimize PRO Study

Inclusion Criteria:

• Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FXsystem for the addendum where applicable) in accordance with the Instructions forUse and local regulations;

• Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by NewYork Heart Association (NYHA) Functional Class II or greater;

• Subject and the treating physician agree that the subject will return for allrequired post procedure follow-up visits;

• Anatomically suitable for transfemoral TAVR with the Medtronic TAVR system;

• Subject meets the legal minimum age to provide Informed Consent based on localregulatory requirements.

Exclusion Criteria:

• Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable) in accordance with the Instructions for Use

• Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ or FX system (whereapplicable);

• Previous aortic valve replacement

• Reduced ventricular function with left ventricular ejection fraction (LVEF) <35% asmeasured by resting echocardiogram;

• Frailty assessments identify:

• Subject is <80 years of age and three or more of the following apply; ORsubject is > 80 years of age and two or more of the following apply

• Wheelchair bound

• Resides in an institutional care facility (e.g. nursing home, skilled carecenter)

• Body Mass Index <20kg/m2

• Grip strength <16kg

• Katz Index score ≤4

• Albumin <3.5 g/dL

• Bicuspid valve verified;

• Aortic root angulation (angle between plane of aortic valve annulus and horizontalplane/vertebrae) > 70°.

• Implanted with pacemaker or ICD;

• Prohibitive left ventricular outflow tract calcification;

• Estimated life expectancy of less than 12 months due to associated non- cardiacco-morbid conditions;

• Other medical, social, or psychological conditions that in the opinion of theInvestigator precludes the subject from appropriate consent, adherence to theprotocol required follow-up exams;

• Currently participating in an investigational drug or another device trial (excluding registries);

• Need for emergency surgery for any reason.

• Subject is less than legal age of consent, legally incompetent, or otherwisevulnerable*.

• Notes: Vulnerable subjects include individuals whose willingness to volunteerin a clinical investigation could be unduly influenced by the expectation,whether justified or not, of benefits associated with participation or ofretaliatory response from senior members of a hierarchy in case of refusal toparticipate. EXAMPLE Individuals with lack of or loss of autonomy due toimmaturity or through mental disability, persons in nursing homes, children,impoverished persons, subjects in emergency situations, ethnic minority groups,homeless persons, nomads, refugees, and those incapable of giving informedconsent. Other vulnerable subjects include, for example, members of a groupwith a hierarchical structure such as university students, subordinate hospitaland laboratory personnel, employees of the sponsor, members of the armedforces, and persons kept in detention.