PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

Overview

About this study

The purpose of this study is to demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤ 72 hours) after transcatheter aortic valve replacement (TAVR).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access.
  • Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
  • Subject (or legal representative) provides written informed consent.

Exclusion Criteria:

  • Subject has arterial stenosis > 70% in either the left common carotid artery or the brachiocephalic artery.
  • Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
  • Subject has compromised blood flow to the right upper extremity.
  • Subject has access vessels with excessive tortuosity.
  • Subject has uncorrected bleeding disorders.
  • Subject is contraindicated for anticoagulant and antiplatelet therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mohamad Adnan Alkhouli, M.D.

Contact us for the latest status

Contact information:

Amanda Biddle R.N.

(507) 255-6133

DLRSTValveResCoor@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20484364

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