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

Boston Scientific

Status

Completed

Conditions

Stroke

Treatments

Device: Sentinel® Cerebral Protection System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04149535

S2453

Details and patient eligibility

About

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).

Enrollment

3,000 patients

Sex

All

Volunteers

No Healthy Volunteers

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.