RecruitingNot ApplicableNCT03003299

PARTNER 3 Trial - Aortic Valve-in-Valve

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

Sponsor

Edwards Lifesciences

Enrollment

125 participants

Start Date

Jan 5, 2017

Study Type

INTERVENTIONAL

Conditions

Aortic Stenosis Aortic Stenosis, Severe

Summary

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Edwards SAPIEN 3/SAPIEN 3 Ultra THV for people with aortic stenosis and aortic stenosis, severe. The study is currently recruiting participants at 51 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEdwards SAPIEN 3/SAPIEN 3 Ultra THV

Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Locations(51)

Banner University Medical Center

Phoenix, Arizona, United States

University of California Los Angeles

Los Angeles, California, United States

Sutter Medical Center

Sacramento, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

UC Health Northern Colorado/Medical Center of the Rockies

Loveland, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

JFK Medical Center/ Atlantic Clinical Research Collaborative

Atlantis, Florida, United States

University of Florida, Gainesville

Gainesville, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern University Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Northshore University HealthSystem

Evanston, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri, United States

Washington University/ Barnes-Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Newark Beth Israel

Newark, New Jersey, United States

University of Buffalo

Buffalo, New York, United States

Winthrop University Hospital

Mineola, New York, United States

New York University (NYU) Langone Medical Center

New York, New York, United States

Cornell University

New York, New York, United States

Columbia University Medical Center/ New York Presbyterian Hospital

New York, 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, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Providence Heart & Vascular Institute

Portland, Oregon, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Saint Thomas Health Services

Nashville, Tennessee, United States

Austin Heart, PLLC

Austin, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

The Heart Hospital Baylor Plano

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Heart and vascular Instritute (Fairfax Inova)

Fairfax, Virginia, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

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NCT03003299

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