Description
Brief Summary: Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. Detailed Description: 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: Moderate AS, defined as follows by transthoracic echo (TTE) at rest: Max aortic velocity = 3.0 m/sec and < 4.0 m/sec, and Mean aortic gradient = 20.0 mmHg and < 40.0 mmHg, and AVA >1.0 cm2 and < 1.5 cm2 NYHA class = II and symptoms of AS, including but not limited to: Dyspnea at rest or on exertion Fatigue Angina Syncope in the absence of another identifiable cause LVEF > 20% by 2-D echo Any of the following HF event or hospitalization for heart failure within 1 calendar year prior to qualifying echo NT proBNP = 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior to or within 2 weeks after qualifying echo, Global longitudinal strain =15% (absolute value) at qualifying echo, or E/e' (average of medial and lateral velocities) = 14.0 at qualifying echo Key Exclusion Criteria: Age < 65 years Class I indication for cardiac surgery Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm Not anatomically suitable for transfemoral TAVR with the trial device In need of and suitable for coronary revascularization per Heart Valve Team Documented history of cardiac amyloidosis
