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Controlled Arterial Protection to Ultimately Remove Embolic Material (CAPTURE-1)

E

EmStop

Status

Enrolling

Conditions

Aortic Valve Stenosis

Treatments

Device: The EmStop Embolic Protection System (EmStop System)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06103591
EMS-CL-5000

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

21 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical & Angiographic Inclusion Criteria

  1. Between 21 and 90 years of age at the time of consent

  2. 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

  3. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures

  4. Willing and able to comply with the protocol-specified procedures and assessments

  5. 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

  1. Requires urgent or emergent TAVR procedure
  2. Contraindicated to MRI
  3. Previously implanted aortic or mitral valve bioprosthesis
  4. Hepatic failure (Child-Pugh class C)
  5. Hypercoagulable state that cannot be corrected by additional periprocedural heparin
  6. 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.
  7. Acute myocardial infarction within 30 days of the planned index procedure
  8. Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
  9. 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)
  10. Left ventricular ejection fraction ≤30% within 3 months prior to procedure
  11. 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
  12. Known allergy or sensitivity to nickel-titanium
  13. Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or white blood cell (WBC) >15,000 IU
  14. Undergoing therapeutic thrombolysis
  15. History of bleeding diathesis or a coagulopathy
  16. 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.
  17. Currently participating in another drug or device clinical study
  18. 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
  19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

EmStop Embolic Protection System
Experimental group
Description:
Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).
Treatment:
Device: The EmStop Embolic Protection System (EmStop System)

Trial contacts and locations

2

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Central trial contact

Emily Vollbrecht; Scott Thome

Data sourced from clinicaltrials.gov

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