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

Stroke Clinical Trial

— PROTECTED TAVR  

Official title:

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149535
• Other study ID #: S2453
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Sentinel® Cerebral Protection System
cerebral embolic protection system

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside
Australia	Monash Medical Center	Clayton	Victoria
Denmark	Aarhus University Hospital	Aarhus
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	København
France	CHU La Timone Hospital	Marseille
France	Clinique Pasteur	Toulouse
Germany	Heart Center Leipzig	Bad Segeberg
Germany	Herzzentrum Dresden GmbH	Dresden
Germany	University Hospital Frankfurt	Frankfurt
Germany	Universitaetsklinikum Schleswig-Holstein	Lübeck
Germany	LMU Klinikum der Universität München	Münich
Germany	Universitaetsklinikum Ulm	Ulm
Italy	Maria Cecilia Hospital SPA	Cotignola
Italy	Fondazione Centro San Raffaele	Milan
Italy	Policlinico San Donato	San Donato	Milanese
United States	Piedmont Hosptial	Atlanta	Georgia
United States	Heart Hospital of Austin	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Kaleida Health	Buffalo	New York
United States	Lahey Clinic Hospital	Burlington	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Heart and Vascular	Dallas	Texas
United States	Mercy Hospital Medical Center	Des Moines	Iowa
United States	Englewood Medical Center	Englewood	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	The Methodist Hospital	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Research Medical Center	Kansas City	Missouri
United States	Sparrow Hospital	Lansing	Michigan
United States	South Denver Cardiology Associates PC and Swedish medical center	Littleton	Colorado
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Wellstar	Marietta	Georgia
United States	Baptist Memorial	Memphis	Tennessee
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	NYU Winthrop	Mineola	New York
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Community Munster	Munster	Indiana
United States	Centennial Medical Center	Nashville	Tennessee
United States	Vanderbilt	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Creighton - Bergan Cardiology	Omaha	Nebraska
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Oregon Health Sciences University	Portland	Oregon
United States	Baylor Scott and White	Round Rock	Texas
United States	University of California, Davis Medical Center	Sacramento	California
United States	Methodist Healthcare System of San Antonio dba Methodist Hospital	San Antonio	Texas
United States	Kaiser Foundation Hospital - San Francisco	San Francisco	California
United States	Intercoastal Medical Group	Sarasota	Florida
United States	St. Johns Hospital	Springfield	Illinois
United States	Tampa General Hospital	Tampa	Florida
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Tucson Medical Center	Tucson	Arizona
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina
United States	Lankenau	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	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.	<=72 hours