The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Mission Health
Asheville, North Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Number of Participants With Procedural Success
Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference
Time frame: During the procedure
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)
Time frame: 30 days follow-up
Average Number of Captured Embolic Debris
Device filters were shipped to an independent pathology core laboratory where debris were counted and assessed
Time frame: During the procedure
Average Number of Captured Particles ≥140 μm in Diameter
Assessed by an independent pathology core laboratory
Time frame: Procedural
Total Acute Infarct Burden
As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. A baseline DW-MRI was collected and evaluated in comparison to the post-procedure DW-MRI.
Time frame: 14 days pre-procedure to 18-36 hours post-procedure
Occurrence of Transient Ischemic Attack (TIA)
Time frame: 30 days
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