Evolut™ EXPAND TAVR II Pivotal Trial
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: April 27, 2022
End Date: December 01, 2034
Hang Nguyen
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
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Conditions:
- Aortic Valve Stenosis