PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
- Conditions
- Stroke
- Interventions
- Device: Sentinel® Cerebral Protection System
- Registration Number
- NCT04149535
- Lead Sponsor
- Boston Scientific Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR with Sentinel Sentinel® Cerebral Protection System Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
- Primary Outcome Measures
Name Time Method The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) <=72 hours 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Lahey Clinic Hospital
🇺🇸Burlington, Massachusetts, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Piedmont Hosptial
🇺🇸Atlanta, Georgia, United States
Baylor Heart and Vascular
🇺🇸Dallas, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
CHU La Timone Hospital
🇫🇷Marseille, France
Kaiser Foundation Hospital - San Francisco
🇺🇸San Francisco, California, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt
🇺🇸Nashville, Tennessee, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
🇺🇸San Antonio, Texas, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, 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
Intercoastal Medical Group
🇺🇸Sarasota, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
St. Johns Hospital
🇺🇸Springfield, Illinois, United States
Wellstar
🇺🇸Marietta, Georgia, United States
Community Munster
🇺🇸Munster, Indiana, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Kaleida Health
🇺🇸Buffalo, New York, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Englewood Medical Center
🇺🇸Englewood, New Jersey, United States
Creighton - Bergan Cardiology
🇺🇸Omaha, Nebraska, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
NYU Winthrop
🇺🇸Mineola, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Baptist Memorial
🇺🇸Memphis, Tennessee, United States
Lankenau
🇺🇸Wynnewood, Pennsylvania, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Baylor Scott and White
🇺🇸Round Rock, Texas, United States
Monash Medical Center
🇦🇺Clayton, Victoria, Australia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Rigshospitalet
🇩🇰København, Denmark
Clinique Pasteur
🇫🇷Toulouse, France
The Prince Charles Hospital
🇦🇺Chermside, Australia
Heart Center Leipzig
🇩🇪Bad Segeberg, Germany
Herzzentrum Dresden GmbH
🇩🇪Dresden, Germany
University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Policlinico San Donato
🇮🇹San Donato, Milanese, Italy
Universitaetsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
LMU Klinikum der Universität München
🇩🇪Münich, Germany
Fondazione Centro San Raffaele
🇮🇹Milan, Italy
Maria Cecilia Hospital SPA
🇮🇹Cotignola, Italy
Mercy Hospital Medical Center
🇺🇸Des Moines, Iowa, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States