Evolut™ EXPAND TAVR II Pivotal Trial

Key Inclusion Criteria: o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL: * AVA \>1.0 cm² and \<1.5cm²; or * AVA ≤ 1.0 cm² with AVAI \> 0.6cm²/m² if BMI \< 30 kg/m²: or * AVA ≤ 1.0 cm² with AVAI \> 0.5cm²/m² if BMI ≥ 30 kg/m²: and * Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or * Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg Any of the following at-risk features: * Symptoms of AS, defined as: * NYHA ≥ Class II, or * Reduced functional capacity, defined as * 6MWT \< 300 meters, or * \< 85% of age-sex predicted METs on exercise tolerance testing (ETT) * 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: * Global longitudinal strain ≤16% (absolute value), or * E/e' ≥ 14.0 (average of medial and lateral velocities), or * Diastolic dysfunction ≥ Grade II, or * LVEF \< 60% * Stroke Volume Index \< 35 ml/m² * 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: * Age \< 65 years * LVEF ≤ 20% by 2-D echo * Class I indication for cardiac surgery * Contraindication for placement of a bioprosthetic valve * Documented history of cardiac amyloidosis

Reproduced word-for-word from the public registry record — the study team can answer questions about it.