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View important safety information regarding the commercial TAVI device used in the trial by visiting the link below.
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.
~650 randomized subjects
Australia, Canada, Europe, Israel, Japan, New Zealand, and United States
10 years of follow-up
Multicenter, international, prospective, randomized
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.
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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