PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

Last updated: April 25, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

SAPIEN 3 / SAPIEN 3 Ultra

SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Clinical Study ID

NCT04889872
2021-01
  • Ages > 65
  • All Genders

Study Summary

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. 65 years of age or older at time of randomization

  2. Moderate aortic stenosis

  3. Subject has symptoms or evidence of cardiac damage/dysfunction

  4. The subject or subject's legal representative has been informed of the nature of thestudy, agrees to its provisions, and has provided written informed consent.

Exclusion

Key Exclusion Criteria:

  1. Native aortic annulus size unsuitable for the THV

  2. Anatomical characteristics that would preclude safe transfemoral placement of theintroducer sheath or safe passage of the delivery system

  3. Aortic valve is unicuspid or non-calcified

  4. Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severeraphe/leaflet calcification

  5. Pre-existing mechanical or bioprosthetic aortic valve

  6. Severe aortic regurgitation

  7. Prior balloon aortic valvuloplasty to treat severe AS

  8. LVEF < 20%

  9. Left ventricular outflow tract calcification that would increase the risk of annularrupture or significant paravalvular leak post-TAVR

  10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation

  11. Coronary or aortic valve anatomy that increases the risk of coronary arteryobstruction post-TAVR

Study Design

Total Participants: 2250
Treatment Group(s): 2
Primary Treatment: SAPIEN 3 / SAPIEN 3 Ultra
Phase:
Study Start date:
October 12, 2021
Estimated Completion Date:
June 30, 2037

Study Description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Connect with a study center

  • The Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St. Paul's Hospital

    Vancouver, British Columbia V6E1M7
    Canada

    Site Not Available

  • Hamiton Health Services

    Hamilton, Onterio L8L 2X2
    Canada

    Site Not Available

  • Kokura Memorial Hospital

    Fukuoka, Kyushu 802-8555
    Japan

    Site Not Available

  • Sendai Kousei Hospital

    Sendai, Miyagi 981-0914
    Japan

    Site Not Available

  • Sakakibara Heart Institute

    Fuchu, Tokyo 183-0003
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku, Tokyo 160-8582
    Japan

    Site Not Available

  • AMC Amsterdam

    Amsterdam, North Holland 1105 AZ
    Netherlands

    Site Not Available

  • Leiden Universitair Medisch Centrum

    Leiden, South Holland 2333
    Netherlands

    Site Not Available

  • Erasmus Rotterdam

    Rotterdam, South Holland 3015
    Netherlands

    Site Not Available

  • Hôpitaux Universitaire de Genève

    Geneva, 1205
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Heart Center LLC, Huntsville

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Tucson Medical Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Huntington Hospital

    Pasadena, California 91105
    United States

    Site Not Available

  • Eisenhower Desert Cardiology Center

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • Bay Area Structural Heart at Sutter Health

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Kaiser San Francisco Medical Center

    San Francisco, California 94118
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Stanford Univeristy

    Stanford, California 94305
    United States

    Active - Recruiting

  • UC Health Medical Center of the Rockies

    Loveland, Colorado 80538
    United States

    Active - Recruiting

  • Yale Universtiy

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • The Cardiac & Vascular Institute Research Foundation

    Gainesville, Florida 32605
    United States

    Site Not Available

  • Baptist Health Research Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Sarasota Memorial Health Care System

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Emory University Atlanta

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Saint Alphonsus

    Boise, Idaho 83704
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Alexian Brothers Hospital

    Lisle, Illinois 60532
    United States

    Active - Recruiting

  • Ascension Via Christi St. Francis

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Louisiana State University

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Ochsner Clinical Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Massachusetts General Hospital Boston

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Minneapolis Heart Institue, St. Paul's

    Minneapolis, Minnesota 55102
    United States

    Active - Recruiting

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota 56303
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City Mid America

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • St. Patrick Hospital

    Missoula, Montana 59802
    United States

    Site Not Available

  • Mary Hitchcock Memorial Hospital

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Atlantic Health System Hospital Corp - Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • University of Buffalo Kaleida Health

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center/NYPH

    New York, New York 10032
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Rochester General Hospital

    Rochester, New York 14621
    United States

    Active - Recruiting

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Moses Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Mount Carmel Health System

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Kaiser Permanente Northwest

    Clackamas, Oregon 97015
    United States

    Site Not Available

  • Legacy Emanuel Medical Center

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Providence Heart & Vascular Institute Portland

    Portland, Oregon 97225
    United States

    Site Not Available

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Pinnacle Health Harrisburg

    Wormleysburg, Pennsylvania 17043
    United States

    Site Not Available

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Baptist Memorial Hospital Memphis

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Methodist Le Bonheur Healthcare

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Parkwest Medical Center

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Saint Thomas Health

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Ascension Texas Cardiovascular

    Austin, Texas 78705
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • HCA Houston Healthcare Medical Center

    Houston, Texas 77004
    United States

    Active - Recruiting

  • The University of Texas Health Science Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Methodist Hospital of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Kaiser Mid Atlantic

    McLean, Virginia 22102
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98112
    United States

    Active - Recruiting

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