Research Study: EARLY TAVR
Condition:
asymptomatic, severe aortic stenosis
Study Sponsor: Edwards Lifesciences
Study Investigator: Mario Goessl, 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:

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
Eligibility Criteria:

  • Severe aortic stenosis
  • Patient is asymptomatic
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

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!