Controlled Arterial Protection to Ultimately Remove Embolic Material
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- EmStop Inc
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Number of Participants With Procedural Success
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Procedural Success
Time Frame: 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
Time Frame: 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 Outcomes
- Average Number of Captured Embolic Debris(During the procedure)
- Average Number of Captured Particles ≥140 μm in Diameter(Procedural)
- Total Acute Infarct Burden(14 days pre-procedure to 18-36 hours post-procedure)
- Occurrence of Transient Ischemic Attack (TIA)(30 days)