EXPAND TAVR II
Pivotal Trial
  Moderate aortic stenosis is not benign.

About the trial

The purpose of the EXPAND TAVR II Pivotal Trial is to explore the treatment of moderate aortic stenosis (AS) with early transcatheter aortic valve replacement (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.

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

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 is defined as*2
    • AVA > 1.0 cm2 and < 1.5 cm2 and
    • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, or
    • Mean gradient ≥ 20.0 mmHg and < 40.0 mmHg
  • Symptoms
    • NYHA ≥ II, or
    • Reduced functional capacity†
      • 6MWT < 300 m, or
      • < 85% of age/sex predicted METs on treadmill ETT
  • At-risk features (at least one)
    • Elevated E/e’ (≥ 14), or
    • Diastolic dysfunction ≥ Grade II, or
    • Impaired GLS (≤ 16%), or
    • LVEF < 60%, or
    • Stroke volume index < 35 ml/m2, or
    • Elevated NT-PRO BNP (> 600) pg, or
    • Persistent AF or paroxysmal AF episode within 6 months, or
    • Elevated aortic valve calcium score‡ (> 1200 AU for females, > 2000 AU for males), or
    • Previous HF event or hospitalization
  • Anatomically suitable for transfemoral TAVR

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, New Zealand, 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
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Additional information

Inquiries about referring patients or becoming a study site?

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Learn more about the TAVR procedure.

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*

Patients presenting with LVEF < 50%, SVI ≤ 35 ml/m2, AVA of ≤ 1.0 cm2, and Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, or mean gradient ≥ 20 mmHg and < 40 mmHg at rest may undergo low-dose DSE to assess if subject has moderate AS versus low-flow, low-gradient severe AS.

†

In absence of non-cardiopulmonary factors (e.g., orthopedic or neurologic problems).

‡

For patients with concordant AS severity parameters only.

References

1

Strange G, Stewart S, Celermajer D, et al. Poor Long-Term Survival in Patients With Moderate Aortic Stenosis. J Am Coll Cardiol. October 15, 2019;74(15):1851–1863.

2

Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. February 2, 2021;143(5):e35–e71.