Research Study: Optimize Pro
Condition:
symptomatic aortic stenosis
Study Sponsor: Medtronic Cardiovascular
Study Investigator: Santiago Garcia, MD
Study Contact: Jenny Nguyen
jennifer.nguyen@allina.com
612-863-9291
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this 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 post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.
Eligibility Criteria:

Inclusion Criteria:

  • 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.

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!