Last updated on April 2019

The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis


Brief description of study

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Detailed Study Description

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Clinical Study Identifier: NCT02675114

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University of Alabama

Birmingham, AL United States
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Mills/Peninsula Health Services

Burlingame, CA United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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Hoag Hospital

Newport Beach, CA United States
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Stanford Hospital and Clinics

Palo Alto, CA United States
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Sutter Health Sacramento

Sacramento, CA United States
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Kaiser Permanente San Francisco

San Francisco, CA United States
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Hartford

Hartford, CT United States
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Mount Sinai Medical Center

Miami Beach, FL United States
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Florida Hospital

Orlando, FL United States
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Emory University

Atlanta, GA United States
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The Queen's Medical Center

Honolulu, HI United States
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Northwestern University

Chicago, IL United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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Henry Ford Hospital

Detroit, MI United States
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William Beaumont Hospital

Royal Oak, MI United States
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Mayo Clinic

Rochester, MN United States
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Nebraska Heart Institute

Lincoln, NE United States
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Newark Beth Israel

Newark, NJ United States
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Albany

Albany, NY United States
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University of Buffalo

Buffalo, NY United States
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NYU Medical Center

New York, NY United States
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Cornell University

New York, NY United States
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Carolina's Health System

Charlotte, NC United States
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The Christ Hospital, Cincinnati

Cincinnati, OH United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Mount Carmel Health System

Columbus, OH United States
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University of Pennsylvania

Philadelphia, PA United States
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Allegheny General Hospital

Pittsburgh, PA United States
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Lankenau Medical Center

Wynnewood, PA United States
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York Hospital

York, PA United States
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Baptist Memorial Hospital

Memphis, TN United States
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Saint Thomas Health Services

Nashville, TN United States
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Austin Heart

Austin, TX United States
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Intermountain Medical Center

Salt Lake City, UT United States
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University of Virginia

Charlottesville, VA United States
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Fairfax INOVA

Falls Church, VA United States
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University of Washington

Seattle, WA United States
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University of Wisconsin

Madison, WI United States
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Flinders Medical Centre

Bedford Park, Australia
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Recruitment Status: Open


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