View important safety information regarding the commercial TAVI device used in the trial by visiting the link below.
About the trial
The aim 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 ‡2,3:
- AVA >1.0 cm2 & < 1.5 cm2, or
- AVA ≤ 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²:
or - AVA ≤ 1.0 cm² with AVAI > 0.5cm²/m² if BMI ≥ 30 kg/m²:
- AVA ≤ 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²:
- Max aortic velocity ≥ 3.0 m/sec. and < 4.0 m/sec,
or - Mean aortic gradient ≥ 20mm Hg and < 40.0 mmHg
- AVA >1.0 cm2 & < 1.5 cm2, or
- Any of the following at-risk features:
- Symptoms of AS, defined as :
- NYHA ≥ Class II, or
- Reduced functional capacity*
- 6MWT < 300 meters, or
- < 85% of age-sex predicted METs on exercise tolerance testing
- Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
- NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
- Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
- Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or
- Any of the following by the qualifying TTE as assessed by the ECL :
- Global longitudinal strain ≤16% (absolute value), or
- E/e' ≥ 14.0 (average of medial and lateral velocities), or
- Diastolic dysfunction ≥ Grade II, or
- LVEF < 60%
- Stroke Volume Index < 35 ml/m²
- Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
- The subject and the treating physician agree the subject will return for all required follow-up visits
- Symptoms of AS, defined as :
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.
Inquiries about referring patients?
Email rs.expandii-emea@medtronic.com
To learn more about TAVI and the procedure, please visit the link below.
† Please visit clinicaltrials.gov for a list of patient selection criteria. Key inclusion / exclusion criteria refer to protocol revision G. Please, select your patient according to the latest version of the protocol that your site is activated to.
‡ Subjects with low flow (SVI < 35 ml/m²) and reduced LVEF (<50%), AVA ≤ 1.0 cm², and max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec OR mean gradient ≥ 20 mmHg and < 40 mmHg can be included if low dose dobutamine stress echo demonstrates all the following:
- SVI ≥ 35 ml/m², and
- AVA > 1.0 cm² and < 1.5 cm², and
- Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg OR max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec.
Subjects with normal flow (SVI ≥ 35 ml/m²) and preserved LVEF (≥ 50%), AVA ≤ 1.0 cm² and max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec OR mean gradient ≥ 20 mmHg and < 40 mmHg can be included if aortic valve calcium score is < 1200 AU for females and < 2000 AU for males.
* In absence of non-cardiopulmonary factors (e.g., orthopedic or neurologic problems).
** 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
3
Vahanian A, et al. Eur Heart J. 2022;43:561-632.
CAUTION:
Investigational use. Device is being investigated for the treatment of moderate aortic stenosis. Not approved for this use in European Union, Israel, Switzerland and United Kingdom.
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