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.
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)
Trial synopsis
~650 randomized subjects
~100 centers
Australia, Canada, Europe, Israel, Japan, New Zealand, and United States
Trial design§
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.
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.
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.
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.
© 2023 Medtronic. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic™.* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.