Evolut™ EXPAND TAVR II Pivotal Trial
Evolut™ EXPAND TAVR II Pivotal Trial
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Multi-center, international, prospective, randomized study. 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.
Key Inclusion Criteria:
o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:
and
Any of the following at-risk features:
Symptoms of AS, defined as:
NYHA ≥ Class II, or
Reduced functional capacity, defined as
Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or
Any of the following by the qualifying TTE as assessed by the ECL:
Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
The subject and the treating physician agree the subject will return for all required follow-up visits
Key Exclusion Criteria:
Ann Arbor, Michigan 48109-1274, United States
Spokane, Washington 99204, United States
Québec, Quebec G1V 4G5, Canada
Dortmund, 44137, Germany