Pivotal Trial
Moderate aortic stenosis is not benign.

View important safety information regarding the commercial TAVI device used in the trial by visiting the link below.

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 implantation (TAVI) 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

Expand TAVI Data chart with Legenda

Eligibility criteria*

Key inclusion criteria

  • Moderate aortic stenosis
    • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, and
    • Mean gradient ≥ 20.0 mm Hg and < 40.0 mm Hg, and
    • AVA > 1.0 cm2 and < 1.5 cm2
  • NYHA ≥ II and symptoms of aortic stenosis
  • Any of the following:
    • Documented heart failure event, or
    • NT-proBNP > 600 pg/ml, or
    • Peak average GLS ≤ -15.0%, or
    • E/e’ ≥ 14.0
  • LVEF > 20%
  • Anatomically suitable for transfemoral TAVI

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)

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: TAVI with Evolut™ PRO+ TAVI system, or Evolut™ FX TAVI system** and guideline-directed management therapy (GDMT), or GDMT alone
  • Primary effectiveness endpoint: All-cause mortality, HF event, or medical instability leading to AVR or aortic valve re-intervention at 2 years

Clinical trial locations

For details about locations for the EXPAND TAVR II Pivotal Trial, visit the clinicaltrials.gov trial website below.

Illustration of a world map in blue dots

Additional information

Visit clinicaltrials.gov for more information about the EXPAND TAVR II Pivotal Trial.

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

To learn more about TAVI and the procedure, please visit the link below.

Inquiries about referring patients?
Email rs.expandii-emea@medtronic.com


Please visit clinicaltrials.gov for a list of patient selection criteria.

Patients presenting with LVEF < 50%, AVA of ≤ 1.0 cm2, and 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.

Age < 75 years in France


More details available in clinical investigational plan from Medtronic.

** CE mark pending, not available for commercial distribution in the EU.



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.

See the CoreValve™ Evolut™ R, the CoreValve™ Evolut™ PRO and the Evolut™ PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu

For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser. 

The commercial name of the Evolut™ R device is Medtronic CoreValve™ Evolut™ R System, the commercial name of the Evolut™ PRO device is Medtronic CoreValve™ Evolut™ PRO System and the commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System.

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