Controlled Arterial Protection to Ultimately Remove Embolic Material

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Controlled Arterial Protection to Ultimately Remove Embolic Material

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: The EmStop Embolic Protection System (EmStop System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical & Angiographic Inclusion Criteria Between 21 and 90 years of age at the time of consent Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures Willing and able to comply with the protocol-specified procedures and assessments Subject anatomy is compatible with correct device deployment and positioning with: Ability to achieve access with a 21 French equivalent femoral access sheath Ascending aorta length ≥8 cm Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification Exclusion Criteria: Requires urgent or emergent TAVR procedure Contraindicated to MRI Previously implanted aortic or mitral valve bioprosthesis Hepatic failure (Child-Pugh class C) Hypercoagulable state that cannot be corrected by additional periprocedural heparin Planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted up until baseline MRI is obtained. Once baseline MRI is obtained, no additional intra-aortic or intracardiac procedure may occur. Acute myocardial infarction within 30 days of the planned index procedure Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min Documented history of stroke or TIA within the prior 6 months, or any prior stroke with a permanent major disability or deficit (NIHSS >1 at baseline) Left ventricular ejection fraction ≤30% within 3 months prior to procedure History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated Known allergy or sensitivity to nickel-titanium Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or white blood cell (WBC) >15,000 IU Undergoing therapeutic thrombolysis History of bleeding diathesis or a coagulopathy Known or suspected to be pregnant, or is lactating; female subjects of child-bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure. Currently participating in another drug or device clinical study Any other clinical reason, as deemed by the investigators of the study, by which the patient would not be an appropriate candidate for the study Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EmStop Embolic Protection System<br>Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). | Device: The EmStop Embolic Protection System (EmStop System)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device procedural success | Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference | Procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross and histologic evaluation of captured embolic debris | Assessed by an independent pathology core laboratory | Procedural | 
| Average number of captured particles ≥140 μm in diameter | Assessed by an independent pathology core laboratory | Procedural | 
| Total acute infarct burden | As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. This outcome will be evaluated and tabulated to include total lesion count, average (mean) lesion volume and median lesion volume. | 14 days pre-procedure and at 18-36 hours post-procedure | 
| Occurrence of Transient Ischemic Attack (TIA) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement, Aortic Valve Replacement