Optimize PRO Study

Study Overview
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Brief Summary
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The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an optimized TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.

Detailed Description
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This is a post market, multi-center (sites in US/CAN/EMEA/ANZ), prospective, non-randomized study. The addendum is a post market, multi-center (sites in US only), prospective, non-randomized study.

Official Title
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Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study

Conditions
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Symptomatic Aortic Stenosis

Intervention / Treatment
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* Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations; Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater; Subject and the treating physician agree that the subject will return for all required 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 local regulatory 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 (where applicable); Previous aortic valve replacement Reduced ventricular function with left ventricular ejection fraction (LVEF) <35% as measured by resting echocardiogram; Frailty assessments identify: Subject is <80 years of age and three or more of the following apply; OR subject 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 care center) 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 horizontal plane/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- cardiac co-morbid conditions; Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent, adherence to the protocol 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 otherwise vulnerable*. Notes: Vulnerable subjects include individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. EXAMPLE Individuals with lack of or loss of autonomy due to immaturity 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 informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Cohort<br> | Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)<br>* Aortic valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality or all-stroke | All-cause mortality or all-stroke at 30 days. | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Median days from index procedure to discharge | Through discharge up to 7 days post index procedure. | 
| AR | Percentage of subjects with ≥ moderate aortic regurgitation (AR) at discharge | Through discharge up to 7 days post index procedure. | 
| Pacemaker Implantation or Worsening Conduction Disturbance | Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days | 30 days | 
| Depth of Implant (Evolut FX Only) | Percentage of subjects with a Non-Coronary Cusp (NCC) depth of implant between 1.0 and 5.0 mm (Evolut FX Addendum Only) | 30 days | 
| Canting (Evolut FX Addendum Only) | Percentage of subjects with a canting absolute value [NCC- Left Coronary Cusp(LCC)] of ≤ 2.0 mm (Evolut FX Addendum Only) | 30 Days |