Transcatheter Aortic Valve Implantation (TAVI)
EXPAND TAVR II Pivotal trial
View information about the EXPAND TAVR II trial.
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.
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.
Moderate native valvular aortic stenosis and long-term survival:
One- and five-year mortality per increment in peak valve velocity1
Eligibility criteria†
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
Synopsis and design
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+ 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
Trial locations
For locations and other details about the EXPAND II Pivotal trial, visit the trial webpage below.
Use identifier number NCT05149755 to see details on the EXPAND TAVR II Pivotal trial.
Additional information
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