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Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and using the Evolut™ PRO and Evolut™ PRO+ device.
- 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