IRB Study Number 22-138
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.
Inclusion Criteria
- Moderate aortic stenosis (AS) as defined in the study protocol, and measured by TTE
- NYHA class ≥ II and symptoms of AS
- Heart failure event or hospitalization for heart failure within 1 calendar year prior to qualifying echo
- Other inclusion criteria will be assessed by study team
Exclusion Criteria
- Age < 65 years
- Class I indication for cardiac surgery
- Not anatomically suitable for transfemoral TAVR with the trial device
- Other exclusion criteria will be assessed by study team
