Research Study: Evolut EXPAND ll
Condition:
Valvular Disease (Heart Valve Disease), Moderate Aortic Valve Stenosis
Study Sponsor:
Medtronic
Study Investigator:
Dr. Paul Sorajja
Study Contact:
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Eligibility 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
