PROTECT TAVR

Condition: Aortic valve stenosis

Eligibility

Key Inclusion Criteria:

  • Documented aortic valve stenosis and is treated with an approved transcatheter aortic valve replacement device via transfemoral access
  • Has the recommended artery diameter at the site of filter placement
  • Provides written informed consent

Key Exclusion Criteria:

  • 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
  • Compromised blood flow to the right upper extremity

Study Name

Stroke Protection with Sentinel During Transcatheter Aortic Valve Replacement (IRB no. 0000485)

Summary

This study focuses on individuals who have aortic valve stenosis and are scheduled to undergo a transcatheter aortic valve replacement (TAVR) procedure. The purpose of the study is to examine whether the use of the Sentinel device significantly reduces the risk of stroke (≤72 hours) after TAVR. Sentinel is approved for commercial use during TAVR in the U.S.; the device is used to capture and remove embolic debris (plaque that breaks away from an artery or valve and floats in the bloodstream) during TAVR procedures in order to reduce injury to the brain.

Participants will be randomly assigned to one of two study groups. One group will receive the usual TAVR procedure with the Sentinel System, and the other group will receive the usual TAVR procedure without the Sentinel System.

Principal Investigator
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