What is the Purpose of this Study?
The primary safety objective is to demonstrate that the composite rate of all-cause mortality, all stroke, life-threatening or fatal bleeding (BARC Type 3 or 4), acute kidney injury (VARC 3 - Stage IV), hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention at 30 days in the device arm is less than the performance goal.
Eligibility
- 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
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Evolut? EXPAND TAVR II Pivotal Trial