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

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

Alert Indications, Safety, and Warnings

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.

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†
    • 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 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)

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+ TAV and guideline-directed management therapy (GDMT), or
  • GDMT alone

Clinical trial locations

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

See trial locations
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.

Learn more about the trial

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

Learn more about TAVR

Inquiries about referring patients or becoming a study site?
Email rs.expandii@medtronic.com

*

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

†

Patients presenting with LVEF < 50%, AVA of ≤ 1.0 cm2, and mean gradient ≥ 20 mm Hg and < 40 mm Hg at rest may undergo low-dose DSE to assess if subject has moderate AS versus low-flow, low-gradient severe AS.

‡

More details available in clinical investigational plan from Medtronic.

Reference

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.