Evolut™ EXPAND TAVR II Pivotal Trial

Other illness

• Class I indication for cardiac surgery
• Documented history of cardiac amyloidosis

Lab values

• LVEF ≤ 20% by 2-D echo

Age

• Age \< 65 years

Other

• Contraindication for placement of a bioprosthetic valve

• 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