PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

Status: Completed
Location: See all (57) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• 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.

Locations
United States
Arizona
Tucson Medical Center
Tucson
California
Cedars Sinai Medical Center
Los Angeles
University of California, Davis Medical Center
Sacramento
Kaiser Foundation Hospital - San Francisco
San Francisco
Los Robles Regional Medical Center
Thousand Oaks
Colorado
South Denver Cardiology Associates PC and Swedish medical center
Littleton
Connecticut
Hartford Hospital
Hartford
Washington, D.c.
Medstar Washington Hospital Center
Washington
Florida
Intercoastal Medical Group
Sarasota
Tampa General Hospital
Tampa
Georgia
Piedmont Hosptial
Atlanta
Wellstar
Marietta
Iowa
Mercy Hospital Medical Center
Des Moines
University of Iowa Hospitals and Clinics
Iowa City
Illinois
St. Johns Hospital
Springfield
Indiana
Community Munster
Munster
Massachusetts
Massachusetts General Hospital
Boston
Lahey Clinic Hospital
Burlington
Michigan
Sparrow Hospital
Lansing
Minnesota
Abbott Northwestern Hospital
Minneapolis
Missouri
Research Medical Center
Kansas City
North Carolina
Wake Forest University School of Medicine
Winston-salem
Nebraska
Creighton - Bergan Cardiology
Omaha
New Jersey
Englewood Medical Center
Englewood
Jersey Shore University Medical Center
Neptune
New York
Kaleida Health
Buffalo
North Shore University Hospital
Manhasset
NYU Winthrop
Mineola
Ohio
Cleveland Clinic Foundation
Cleveland
Oregon
Oregon Health Sciences University
Portland
Pennsylvania
Lankenau
Wynnewood
Tennessee
Baptist Memorial
Memphis
Centennial Medical Center
Nashville
Vanderbilt
Nashville
Texas
Heart Hospital of Austin
Austin
Baylor Heart and Vascular
Dallas
The Methodist Hospital
Houston
The Heart Hospital Baylor Plano
Plano
Baylor Scott and White
Round Rock
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
Other Locations
Australia
The Prince Charles Hospital
Chermside
Monash Medical Center
Clayton
Denmark
Aarhus University Hospital
Aarhus
Aarhus University Hospital
Aarhus
Rigshospitalet
København
France
CHU La Timone Hospital
Marseille
Clinique Pasteur
Toulouse
Germany
Heart Center Leipzig
Bad Segeberg
Herzzentrum Dresden GmbH
Dresden
University Hospital Frankfurt
Frankfurt
Universitaetsklinikum Schleswig-Holstein
Lübeck
LMU Klinikum der Universität München
Münich
Universitaetsklinikum Ulm
Ulm
Italy
Maria Cecilia Hospital SPA
Cotignola
Fondazione Centro San Raffaele
Milan
Policlinico San Donato
San Donato
Time Frame
Start Date: February 7, 2020
Completion Date: February 1, 2022
Participants
Target number of participants: 3000
Treatments
Experimental: TAVR with Sentinel
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
No Intervention: TAVR without Sentinel
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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