What is the Purpose of this Study?
This study focuses on people who have moderate aortic stenosis, a condition in which the opening in the aortic valve is narrowed and limits blood flow. Recent studies have shown that some patients with moderate stenosis may be at similar risk for heart failure or serious heart-related events as patients with severe aortic stenosis. Therefore, the purpose of this study is to determine whether it is beneficial to replace the narrowed aortic valve before it becomes severely narrowed. Replacement of the aortic valve relieves obstruction to blood flow through the heart, improves symptoms, helps the heart work better, and allows patients to live longer. The 3 devices, PRO+ System, FX TAVR System and FX+ System (referred to as the study device) are considered experimental for use in patients who have moderate narrowing of the aortic valve opening. Participants will be assigned to 1 of 2 groups. One group will undergo a transcatheter aortic valve replacement (TAVR) procedure using the study device along with GDMT (guideline-directed medical therapy). The other group will receive only GDMT and will be closely monitored for progression of their aortic stenosis. If the stenosis becomes severe, they will cross over to receive the TAVR procedure.
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