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

Completed · Not applicable

Conditions studied: Stroke

In brief

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).

Key facts

Study ID

NCT04149535

Run by

Boston Scientific Corporation

People needed

3000

Starts

2020-02-07

Expected to finish

2022-02-01

Last updated by the study team

2023-02-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• Kaiser Foundation Hospital - San Francisco — San Francisco, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• South Denver Cardiology Associates PC and Swedish medical center — Littleton, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Intercoastal Medical Group — Sarasota, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Piedmont Hosptial — Atlanta, Georgia, United States
• Wellstar — Marietta, Georgia, United States
• St. Johns Hospital — Springfield, Illinois, United States
• Community Munster — Munster, Indiana, United States
• Mercy Hospital Medical Center — Des Moines, Iowa, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Clinic Hospital — Burlington, Massachusetts, United States
• Sparrow Hospital — Lansing, Michigan, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Research Medical Center — Kansas City, Missouri, United States
• Creighton - Bergan Cardiology — Omaha, Nebraska, United States
• Englewood Medical Center — Englewood, New Jersey, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Kaleida Health — Buffalo, New York, United States
• Tucson Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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