Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Stroke
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who have documented aortic valve stenosis and is treated with an approved transcatheter aortic valve replacement device via transfemoral access.
    2. Participants who have the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use
    3. Participants must provide written informed consent

You may not be eligible for this study if the following are true:

    1. Participants with arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery
    2. Brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
    3. Has compromised blood flow to the right upper extremity
    4. Has access vessels with excessive tortuosity
    5. Has uncorrected bleeding disorders
    6. Contraindicated for anticoagulant and antiplatelet therapy



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