Evolut™ EXPAND TAVR II Pivotal Trial

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  65 and up

Participation Criteria

Key Inclusion Criteria:

o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:

* AVA \>1.0 cm² and \<1.5cm²; 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:

and

* Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or
* Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg

Any of the following at-risk features:

* Symptoms of AS, defined as:
* NYHA ≥ Class II, or
* Reduced functional capacity, defined as

* 6MWT \< 300 meters, or
* \< 85% of age-sex predicted METs on exercise tolerance testing (ETT)
* 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

Key Exclusion Criteria:

* Age \< 65 years
* LVEF ≤ 20% by 2-D echo
* Class I indication for cardiac surgery
* Contraindication for placement of a bioprosthetic valve
* Documented history of cardiac amyloidosis