Status:
COMPLETED
Controlled Arterial Protection to Ultimately Remove Embolic Material
Lead Sponsor:
EmStop Inc
Collaborating Sponsors:
Bright Research Partners
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
21-90 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06103591
Start Date
December 27 2023
End Date
October 14 2024
Last Update
April 29 2025
Active Locations (2)
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1
Mission Health
Asheville, North Carolina, United States, 28801
2
Centennial Medical Center
Nashville, Tennessee, United States, 37203