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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.
Condition or disease
Symptomatic Aortic Stenosis
Device: Evolut™ PRO and Evolut™ PRO+ System
This is a post market, multi-center (sites in US/CAN/EMEA/ANZ), prospective, non-randomized study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population includes patients with symptomatic native aortic valve stenosis that necessitates valve replacement who meet the criteria for on-label use of the Evolut™ PRO or Evolut™ PRO+ system in accordance with Instructions for Use and local regulations.
Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system 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.
Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ system in accordance with the Instructions for Use
Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ system;
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
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.