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 is defined as ‡2:
- AVA >1.0 cm2 & < 1.5 cm2, AND
- Max aortic velocity ≥ 3.0 m/sec & < 4.0 m/sec, OR
- Mean gradient ≥ 20.0 mmHg & < 40.0 mmHg - Symptoms of AS, defined as
- NYHA ≥ II, OR
- Reduced functional capacity*, defined as:- 6MWT < 300 meters, OR
- < 85% of age/sex predicted METs on exercise tolerance testing
- 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 (>600pg/mL), OR
- Persistent AF or paroxysmal AF episode within six months, OR
- Elevated aortic valve calcium score§ (> 1200 AU for females, > 2,000 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
Trial synopsis
~650 randomized subjects
~100 centers
Australia, Canada, Europe, Israel, Japan, New Zealand, and United States
Trial design†
10 years of follow-up
Pre-market, multi center, international and randomized
- 1:1 randomization: TAVI with Evolut™ PRO+ or FX TAVI system*** and guideline-directed management therapy (GDMT), or GDMT alone
- Primary effectiveness endpoint: All-cause mortality, HF hospitalization or 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. Key inclusion / exclusion criteria refer to protocol revision F. Please, select your patient according to the latest version of the protocol that your site is activated to.
‡ Patients presenting with LVEF < 50%, SVI ≤ 35 ml/m2, AVA of ≤ 1.0 cm2, and vMax ≥ 3.0 m/sec & < 4.0, or 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.
* In absence of non-cardiopulmonary factors (e.g., orthopedic or neurologic problems).
§ For patients with concordant AS severity parameters only.
** Age < 75 years in France.
*** Commercial labeled Evolut FX, is available for use in the trial only in the countries where it is approved for commercial use and also providing allowance per local regulations and regulatory authorities.
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.
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 [published correction appears in Circulation. 2021 Feb 2;143(5):e228] [published correction appears in Circulation. 2021 Mar 9;143(10):e784]. Circulation. 2021;143(5):e35-e71. doi:10.1161/CIR.0000000000000932
See the CoreValve™ Evolut™ R, the CoreValve™ Evolut™ PRO, the Evolut™ PRO+ device and the Evolut™ FX 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, the commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System, and the commercial name of the Evolut™ FX device is Medtronic Evolut™ FX System.
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