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CAUTION: Investigational use. Device is being investigated for the treatment of moderate aortic stenosis. Not approved for this use by the FDA.

About the trial

The purpose of the EXPAND TAVR II Pivotal trial is to explore the treatment of moderate aortic stenosis (AS) with early TAVR before AS becomes severe. Early treatment of AS may help preserve cardiac function, prevent or slow further deterioration in cardiac function, and prevent death in some patients.

Male healthcare professional standing and listening to the heart of an older female patient who is sitting down

Moderate native valvular aortic stenosis and long-term survival:

One- and five-year mortality per increment in peak valve velocity1

Comparison chart of mortality from different stages of aortic stenosis

Eligibility criteria

Key inclusion criteria

  • Moderate aortic stenosis†,2,3 
    • AVA >1.0 cm² and <1.5 cm², or
    • AVA ≤ 1.0 cm² with AVAI > 0.6 cm²/m² if BMI < 30 kg/m², or
    • AVA ≤ 1.0 cm² with AVAI > 0.5 cm²/m² if BMI ≥ 30 kg/m²,

      and 

    • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, or
    • Mean aortic gradient ≥ 20 mmHg and < 40.0 mmHg
  • Any of the following at-risk features:
    • Symptoms of AS, defined as:
    • NYHA ≥ Class II, or
    • Reduced functional capacityǂ
      • 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 one calendar year prior to consent
    • NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
    • Persistent AF or paroxysmal AF episode within six 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
  • 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
  • In need of coronary revascularization
  • Severe aortic regurgitation
  • Severe tricuspid regurgitation
  • Severe mitral regurgitation
  • Moderate or severe mitral stenosis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • LVEF ≤ 20%​
  • Documented history of cardiac amyloidosis
  • Severe LVOT calcification

Synopsis and design

Trial synopsis

Decorative element

~650 randomized subjects

Decorative element

~100 centers

Australia, Canada, Europe, Israel, Japan, and United States

Trial design

Decorative element

10 years of follow-up

Multicenter, international, prospective, randomized

  • 1:1 randomization: TAVR with Evolut™ PRO+ or Evolut™ FX TAV and guideline-directed management therapy (GDMT), or
  • GDMT alone

Trial locations

For locations and other details about the EXPAND II Pivotal trial, visit the trial webpage below.

Use identifier number NCT05149755 to see details on the EXPAND TAVR II Pivotal trial.

Learn more about the trial (open in new window)
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Additional information

Inquiries about referring patients or becoming a study site?

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