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EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Sponsor: Edwards Lifesciences
Summary
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Official title: Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
901
Start Date
2017-07-12
Completion Date
2032-03
Last Updated
2024-05-13
Healthy Volunteers
No
Conditions
Interventions
Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
Locations (77)
Banner University Medical Center
Phoenix, Arizona, United States
Mills Peninsula Health Services
Burlingame, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Huntington Hospital
Pasadena, California, United States
UC Davis Medical Center
Sacramento, California, United States
Kaiser San Francisco Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics Palo Alto
Stanford, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States
Yale University
New Haven, Connecticut, United States
Washington Hospital Center DC
Washington D.C., District of Columbia, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center Chicago
Chicago, Illinois, United States
NorthShore University HealthSystem Research Institution
Evanston, Illinois, United States
Alexian Brothers Hospital Network
Lisle, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare Heart
Saint Cloud, Minnesota, United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States
St. Patrick Hospital
Missoula, Montana, United States
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Albany Medical College
Albany, New York, United States
University at Buffalo - Kaleida Health
Buffalo, New York, United States
NYU Langone Hosptial - Long Island
Mineola, New York, United States
New York University Langone Medical Center
New York, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States
Cornell University
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina's Health System
Charlotte, North Carolina, United States
NC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, United States
The Christ Hospital, Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Mount Carmel Health System
Columbus, Ohio, United States
The Ohio Health Research Institute
Columbus, Ohio, United States
Kaiser Portland
Clackamas, Oregon, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Heart Hospital Baylor Plano
Dallas, Texas, United States
Texas Health Physician Group
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Intermountain Medical Center Salt Lake City
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Heart and Vascular Institute (Fairfax Inova)
Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Carilion Medical Center
Roanoke, Virginia, United States
Providence Everett
Everett, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
CAMC Clinical Trials Center
Charleston, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hamilton Health Sciences
Hamilton, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada