PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
NCT ID: NCT04149535
Last Updated: 2023-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
3000 participants
INTERVENTIONAL
2020-02-07
2022-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVR with Sentinel
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Sentinel® Cerebral Protection System
cerebral embolic protection system
TAVR without Sentinel
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
No interventions assigned to this group
Interventions
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Sentinel® Cerebral Protection System
cerebral embolic protection system
Eligibility Criteria
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Inclusion Criteria
* 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'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.
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Samir Kapadia, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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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 D.C., District of Columbia, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Hosptial
Atlanta, Georgia, United States
Wellstar
Marietta, Georgia, United States
St. Johns Hospital
Springfield, Illinois, United States
Community Munster
Munster, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lahey Clinic Hospital
Burlington, Massachusetts, United States
Sparrow Hospital
Lansing, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
Creighton - Bergan Cardiology
Omaha, Nebraska, United States
Englewood Medical Center
Englewood, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Kaleida Health
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Winthrop
Mineola, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Lankenau
Wynnewood, Pennsylvania, United States
Baptist Memorial
Memphis, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
Heart Hospital of Austin
Austin, Texas, United States
Baylor Heart and Vascular
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Baylor Scott and White
Round Rock, Texas, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Monash Medical Center
Clayton, Victoria, Australia
The Prince Charles Hospital
Chermside, , Australia
Aarhus University Hospital
Aarhus, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
CHU La Timone Hospital
Marseille, , France
Clinique Pasteur
Toulouse, , France
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, , Germany
Policlinico San Donato
San Donato, Milanese, Italy
Maria Cecilia Hospital SPA
Cotignola, , Italy
Fondazione Centro San Raffaele
Milan, , Italy
Countries
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References
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Makkar RR, Gupta A, Waggoner TE, Horr S, Karha J, Satler L, Stoler RC, Alvarez J, Sakhuja R, MacDonald L, Modolo R, Leon MB, Linke A, Kapadia SR. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):17-24. doi: 10.1001/jamacardio.2024.4278.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S2453
Identifier Type: -
Identifier Source: org_study_id
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