Research Study: Evolut EXPAND TAVR II
Condition:
Valvular Disease (Heart Valve Disease)
Study Sponsor:
Medtronic
Study Investigator:
Paul Sorajja, MD
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, symptomatic aortic stenosis.
Eligibility Criteria:
Ages Eligible for Study: 65 Years and older (Older Adult)
Moderate AS, defined as follows by transthoracic echo (TTE) at rest:
- Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, and
- Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, and
- AVA >1.0 cm2 and < 1.5 cm2
NYHA class ≥ II and symptoms of AS, including but not limited to:
- Dyspnea at rest or on exertion
- Fatigue
- Angina
- Syncope in the absence of another identifiable cause
- LVEF > 20% by 2-D echo
Any of the following
- HF event or hospitalization for heart failure within 1 calendar year prior to qualifying echo
- NT proBNP ≥ 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior to or within 2 weeks after qualifying echo,
- Global longitudinal strain ≤15% (absolute value) at qualifying echo, or
- E/e' (average of medial and lateral velocities) ≥ 14.0 at qualifying echo
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
- Not anatomically suitable for transfemoral TAVR with the trial device
- In need of and suitable for coronary revascularization per Heart Valve Team
- Documented history of cardiac amyloidosis