Controlled Arterial Protection to Ultimately Remove Embolic Material

Completed · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT06103591

Run by

EmStop Inc

People needed

15

Starts

2023-12-27

Expected to finish

2024-10-14

Last updated by the study team

2025-04-29

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mission Health — Asheville, North Carolina, United States
• Centennial Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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