Tiny tube vs. open chest: new heart valve battle for Low-Risk patients

NCT ID NCT02675114

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

Summary

This study aims to see if a less invasive procedure to replace a narrowed heart valve is as safe and effective as traditional open-heart surgery for patients who are at low risk for surgery. About 1,000 patients with severe aortic stenosis will be randomly assigned to receive either the new valve via a catheter in the leg or standard surgical replacement. The goal is to control the life-threatening valve disease, and patients will be followed for up to 10 years to compare outcomes like survival, stroke, and hospital stays.

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Contacts and locations

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Locations

Albany

Albany, New York, 12208, United States
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Auckland City Hospital

Grafton, Auckland, 1024, New Zealand
Austin Heart

Austin, Texas, 78756, United States
Banner University Medical Center

Phoenix, Arizona, 85006, United States
Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States
Barnes-Jewish Hospital / Washington University

St Louis, Missouri, 63110, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States
Carolina's Health System

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Central Maine Medical Center

Auburn, Maine, 04210, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States
Cornell University

New York, New York, 10021, United States
Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Emory University

Atlanta, Georgia, 30322, United States
Fairfax INOVA

Falls Church, Virginia, 22042, United States
Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia
Florida Hospital

Orlando, Florida, 32803, United States
Hartford

Hartford, Connecticut, 06102, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Hoag Hospital

Newport Beach, California, 92663, United States
Intermountain Medical Center

Salt Lake City, Utah, 84157, United States
JFK Medical Center / Atlantic Clinical Research Collaborative

Atlantis, Florida, 33462, United States
Kaiser Permanente San Francisco

San Francisco, California, 94115, United States
Keio University

Shinjuku, Tokyo, 160-8582, Japan
Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan
Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medical City Dallas Hospital

Dallas, Texas, 75230, United States
Mills/Peninsula Health Services

Burlingame, California, 94010, United States
Morristown Medical Center / Atlantic Health System Hospital

Morristown, New Jersey, 07962, United States
Mount Carmel Health System

Columbus, Ohio, 43213, United States
Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States
NYU Medical Center

New York, New York, 10016, United States
Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States
Newark Beth Israel

Newark, New Jersey, 07112, United States
NorthShore University HealthSystem Research Institute

Evanston, Illinois, 60201, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States
Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States
Osaka University

Suita, Osaka, 565-0871, Japan
Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States
Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States
Rex Hospital / NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
Rush University Medical Center

Chicago, Illinois, 60612, United States
Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri, 64111, United States
Saint Paul's Hospital

Vancouver, Canada
Saint Thomas Health Services

Nashville, Tennessee, 37205, United States
Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan
Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States
Stanford Hospital and Clinics

Palo Alto, California, 94305, United States
Sutter Health Sacramento

Sacramento, California, 95816, United States
Teikyo University

tabashi City, Tokyo, 173-8606, Japan
The Christ Hospital, Cincinnati

Cincinnati, Ohio, 45219, United States
The Heart Hosptial Baylor Plano

Plano, Texas, 75093, United States
The Queen's Medical Center

Honolulu, Hawaii, 96813, United States
The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States
UC Health Northern Colorado/Medical Center of the Rockies

Loveland, Colorado, 80538, United States
UPR - Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States
UPR - Novant Health Heart and Vascular Institution

Charlotte, North Carolina, 28204, United States
UPR-Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States
University of Alabama

Birmingham, Alabama, 35294, United States
University of Buffalo

Buffalo, New York, 14203, United States
University of California, Los Angeles/Ronald Reagan Medical Center

Los Angeles, California, 90095, United States
University of Florida, Gainesville

Gainesville, Florida, 32610, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Virginia

Charlottesville, Virginia, 22904, United States
University of Washington

Seattle, Washington, 98195, United States
University of Wisconsin

Madison, Wisconsin, 53792, United States
William Beaumont Hospital

Royal Oak, Michigan, 48073, United States
Winthrop-University Hospital

Mineola, New York, 11501, United States
York Hospital

York, Pennsylvania, 17403, United States

Conditions

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AORTIC STENOSIS