Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™
 PRO+ TAVR System for the treatment of moderate, symptomatic aortic stenosis and severe,
 asymptomatic aortic stenosis.
Single-arm, two-cohort, descriptive, multi-center, international

 All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups
 will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually
 through 5 years.
Key Inclusion Criteria: Cohort A (Moderate, Symptomatic Aortic Stenosis)

 -  Moderate aortic stenosis (aortic valve area >1.0 cm^2 & <1.5 cm^2)

 -  New York Heart Association (NYHA) functional classification ≥II, with symptoms
 attributable to aortic stenosis

 -  Left Ventricular Ejection Fraction (LVEF) >20% by 2-D echo

 Key Exclusion Criteria: Cohort A (Moderate, Symptomatic Aortic Stenosis)

 -  Age <65 years

 -  Class I indication for cardiac surgery

 -  Bicuspid, unicuspid, or quadricuspid aortic valve

 -  In need of and suitable for coronary revascularization

 Key Inclusion Criteria: Cohort B (Severe, Asymptomatic Aortic Stenosis)

 -  Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area
 index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec

 -  Subject denies symptoms attributable to aortic stenosis, including but not limited to:

 -  Dyspnea on rest or exertion

 -  Angina

 -  Syncope in the absence of another identifiable cause

 -  Fatigue

 -  Left Ventricular Ejection Fraction (LVEF) >50%

 Key Exclusion Criteria: Cohort B (Severe, Asymptomatic Aortic Stenosis)

 -  Age <65 years

 -  Class I indication for cardiac surgery

 -  Bicuspid, unicuspid, or quadricuspid aortic valve

 -  In need of and suitable for coronary revascularization