Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Conditions studied

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement, Aortic Valve Stenosis

What is being tested

• DEVICE: EMBLOK™ Embolic Protection System ("EMBLOK EPS")
• DEVICE: SENTINEL™ Cerebral Protection System

What it measures

• Debris capture, defined as the average number of captured particles ≥150 µm in diameter, as assessed by independent histologic analysis, The co-primary filtration efficacy endpoint is debris capture, defined as the average number of captured particles ≥150 μm in diameter, as assessed by independent histologic analysis., Evaluated at the time of the TAVR procedure (during the intervention/procedure)
• Incidence of the composite of all-cause mortality, all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), according to VARC-2 definitions, The primary safety and efficacy endpoint is combined safety and efficacy at 30 days, defined as a composite of the following VARC-2 defined components: * All-cause mortality * All stroke (disabling or non-disabling) and transient ischemic attack (TIA) * Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), Evaluated at 30-day post-procedure (TAVR) follow-up visit

Working with

Yale Cardiovascular Research Group