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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT04149535
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Study Start: 2020-02-07
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Results First Submitted: 2022-11-18
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Results First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	<=72 hours	All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.

Trial Locations

Locations (56)

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

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, District of Columbia, United States

Intercoastal Medical Group; 🇺🇸 Sarasota, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

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