Clinical trial NCT04149535: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Official title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
timeFrame: <=72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital - San Francisco
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC and Swedish medical center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hosptial
state: Georgia
city: Marietta
country: United States
facility: Wellstar
state: Georgia
city: Springfield
country: United States
facility: St. Johns Hospital
state: Illinois
city: Munster
country: United States
facility: Community Munster
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Omaha
country: United States
facility: Creighton - Bergan Cardiology
state: Nebraska
city: Englewood
country: United States
facility: Englewood Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mineola
country: United States
facility: NYU Winthrop
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Wynnewood
country: United States
facility: Lankenau
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Round Rock
country: United States
facility: Baylor Scott and White
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio dba Methodist Hospital
state: Texas
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Clayton
country: Australia
facility: Monash Medical Center
state: Victoria
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: København
country: Denmark
facility: Rigshospitalet
city: Marseille
country: France
facility: CHU La Timone Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Segeberg
country: Germany
facility: Heart Center Leipzig
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Münich
country: Germany
facility: LMU Klinikum der Universität München
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: San Donato
country: Italy
facility: Policlinico San Donato
state: Milanese
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital SPA
city: Milan
country: Italy
facility: Fondazione Centro San Raffaele
Study officials:
affiliation: The Cleveland Clinic
name: Samir Kapadia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messe SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022 Oct 6;387(14):1253-1263. doi: 10.1056/NEJMoa2204961. Epub 2022 Sep 17.