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:
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Conditions: Stroke
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Age: Between 18 - 110 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants who have documented aortic valve stenosis and is treated with an approved transcatheter aortic valve replacement device via transfemoral access.
- Participants who have the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use
- Participants must provide written informed consent
You may not be eligible for this study if the following are true:
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- Participants with arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery
- Brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
- Has compromised blood flow to the right upper extremity
- Has access vessels with excessive tortuosity
- Has uncorrected bleeding disorders
- Contraindicated for anticoagulant and antiplatelet therapy
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.