Controlled Arterial Protection to Ultimately Remove Embolic Material

Not Applicable

Completed

Conditions: Aortic Valve Stenosis

Interventions: Device: The EmStop Embolic Protection System (EmStop System)

Registration Number: NCT06103591

Lead Sponsor: EmStop Inc

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EmStop Embolic Protection System	The EmStop Embolic Protection System (EmStop System)	Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	During the procedure	Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days	30 days follow-up	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)

Secondary Outcome Measures

Name	Time	Method
Average Number of Captured Embolic Debris	During the procedure	Device filters were shipped to an independent pathology core laboratory where debris were counted and assessed
Average Number of Captured Particles ≥140 μm in Diameter	Procedural	Assessed by an independent pathology core laboratory
Total Acute Infarct Burden	14 days pre-procedure to 18-36 hours post-procedure	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.
Occurrence of Transient Ischemic Attack (TIA)	30 days