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

Last updated: September 5, 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

  • The Prince Charles Hospital

    Chermside 6943582, Queensland 2152274 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

  • Royal Adelaide Hospital

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park 2076918, South Australia 2061327 5042
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • St. Paul's Hospital

    Vancouver, British Columbia V6E1M7
    Canada

    Site Not Available

  • St. Paul's Hospital

    Vancouver 6173331, British Columbia 5909050 V6E1M7
    Canada

    Site Not Available

  • Hamiton Health Services

    Hamilton, Onterio L8L 2X2
    Canada

    Site Not Available

  • Hamiton Health Services

    Hamilton 5969782, Onterio L8L 2X2
    Canada

    Site Not Available

  • Kokura Memorial Hospital

    Fukuoka, Kyushu 802-8555
    Japan

    Site Not Available

  • Kokura Memorial Hospital

    Fukuoka 1863967, Kyushu 802-8555
    Japan

    Site Not Available

  • Sendai Kousei Hospital

    Sendai, Miyagi 981-0914
    Japan

    Site Not Available

  • Sendai Kousei Hospital

    Sendai 2111149, Miyagi 2111888 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

  • Sakakibara Heart Institute

    Fuchū 11611632, Tokyo 1850144 183-0003
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku 11790353, Tokyo 1850144 160-8582
    Japan

    Site Not Available

  • AMC Amsterdam

    Amsterdam, North Holland 1105 AZ
    Netherlands

    Site Not Available

  • AMC Amsterdam

    Amsterdam 2759794, North Holland 2749879 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

  • Leiden Universitair Medisch Centrum

    Leiden 2751773, South Holland 2743698 2333
    Netherlands

    Site Not Available

  • Erasmus Rotterdam

    Rotterdam 2747891, South Holland 2743698 3015
    Netherlands

    Site Not Available

  • Hôpitaux Universitaire de Genève

    Geneva, 1205
    Switzerland

    Site Not Available

  • Hôpitaux Universitaire de Genève

    Geneva 2660646, 1205
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zurich 2657896, 8091
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Heart Center LLC, Huntsville

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Heart Center LLC, Huntsville

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Active - Recruiting

  • Tucson Medical Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Tucson Medical Center

    Tucson 5318313, Arizona 5551752 85712
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Huntington Hospital

    Pasadena, California 91105
    United States

    Site Not Available

  • Eisenhower Desert Cardiology Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • 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

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Stanford Univeristy

    Stanford, California 94305
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • Huntington Hospital

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • Eisenhower Desert Cardiology Center

    Rancho Mirage 5386015, California 5332921 92270
    United States

    Active - Recruiting

  • Bay Area Structural Heart at Sutter Health

    San Francisco 5391959, California 5332921 94109
    United States

    Active - Recruiting

  • Kaiser San Francisco Medical Center

    San Francisco 5391959, California 5332921 94118
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara 5392952, California 5332921 93105
    United States

    Active - Recruiting

  • Stanford Univeristy

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

  • UC Health Medical Center of the Rockies

    Loveland, Colorado 80538
    United States

    Site Not Available

  • UC Health Medical Center of the Rockies

    Loveland 5579368, Colorado 5417618 80538
    United States

    Active - Recruiting

  • Yale Universtiy

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale Universtiy

    New Haven 4839366, Connecticut 4831725 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

    Site Not Available

  • Sarasota Memorial Health Care System

    Sarasota, Florida 34239
    United States

    Site Not Available

  • The Cardiac & Vascular Institute Research Foundation

    Gainesville 4156404, Florida 4155751 32605
    United States

    Site Not Available

  • Baptist Health Research Center

    Jacksonville 4160021, Florida 4155751 32207
    United States

    Active - Recruiting

  • Sarasota Memorial Health Care System

    Sarasota 4172131, Florida 4155751 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

  • Emory University Atlanta

    Atlanta 4180439, Georgia 4197000 30308
    United States

    Active - Recruiting

  • Piedmont Heart Institute

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Active - Recruiting

  • Saint Alphonsus

    Boise, Idaho 83704
    United States

    Site Not Available

  • Saint Alphonsus

    Boise 5586437, Idaho 5596512 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

    Site Not Available

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Alexian Brothers Hospital

    Lisle 4900080, Illinois 4896861 60532
    United States

    Active - Recruiting

  • Ascension Via Christi St. Francis

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Ascension Via Christi St. Francis

    Wichita 4281730, Kansas 4273857 67226
    United States

    Active - Recruiting

  • Louisiana State University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Ochsner Clinical Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Louisiana State University

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Active - Recruiting

  • Ochsner Clinical Foundation

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Site Not Available

  • Massachusetts General Hospital Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital Boston

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Minneapolis Heart Institue, St. Paul's

    Minneapolis, Minnesota 55102
    United States

    Site Not Available

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Minneapolis Heart Institue, St. Paul's

    Minneapolis 5037649, Minnesota 5037779 55102
    United States

    Active - Recruiting

  • CentraCare Heart and Vascular Center

    Saint Cloud 5044407, Minnesota 5037779 56303
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City Mid America

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City Mid America

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Active - Recruiting

  • St. Patrick Hospital

    Missoula, Montana 59802
    United States

    Site Not Available

  • St. Patrick Hospital

    Missoula 5666639, Montana 5667009 59802
    United States

    Site Not Available

  • Mary Hitchcock Memorial Hospital

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Mary Hitchcock Memorial Hospital

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Active - Recruiting

  • Atlantic Health System Hospital Corp - Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • 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

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Atlantic Health System Hospital Corp - Morristown Medical Center

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Active - Recruiting

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • The Valley Hospital

    Ridgewood 5103269, New Jersey 5101760 07450
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • University of Buffalo Kaleida Health

    Buffalo, New York 14203
    United States

    Site Not Available

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • 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

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • University of Buffalo Kaleida Health

    Buffalo 5110629, New York 5128638 14203
    United States

    Active - Recruiting

  • NYU Langone Hospital - Long Island

    Mineola 5127134, New York 5128638 11501
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center/NYPH

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Rochester General Hospital

    Rochester 5134086, New York 5128638 14621
    United States

    Active - Recruiting

  • St. Francis Hospital

    Roslyn 5134415, New York 5128638 11576
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • Moses Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Moses Cone Memorial Hospital

    Greensboro 4469146, North Carolina 4482348 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

  • The Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Mount Carmel Health System

    Columbus 4509177, Ohio 5165418 43213
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa 4553433, Oklahoma 4544379 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

    Site Not Available

  • Providence Heart & Vascular Institute Portland

    Portland, Oregon 97225
    United States

    Site Not Available

  • Kaiser Permanente Northwest

    Clackamas 5719308, Oregon 5744337 97015
    United States

    Site Not Available

  • Legacy Emanuel Medical Center

    Portland 5746545, Oregon 5744337 97227
    United States

    Active - Recruiting

  • Providence Heart & Vascular Institute Portland

    Portland 5746545, Oregon 5744337 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

    Site Not Available

  • Allegheny Singer Research Institute

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Active - Recruiting

  • UPMC Presbyterian Shadyside

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Pinnacle Health Harrisburg

    Wormleysburg 5220137, Pennsylvania 6254927 17043
    United States

    Site Not Available

  • Lankenau Medical Center

    Wynnewood 5220230, Pennsylvania 6254927 19096
    United States

    Active - Recruiting

  • Baptist Memorial Hospital Memphis

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • 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

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Baptist Memorial Hospital Memphis

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • Methodist Le Bonheur Healthcare

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • Parkwest Medical Center

    Knoxville 4634946, Tennessee 4662168 37923
    United States

    Active - Recruiting

  • Saint Thomas Health

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Ascension Texas Cardiovascular

    Austin, Texas 78705
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • HCA Houston Healthcare Medical Center

    Houston, Texas 77004
    United States

    Site Not Available

  • The University of Texas Health Science Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Methodist Hospital of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Ascension Texas Cardiovascular

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75235
    United States

    Active - Recruiting

  • HCA Houston Healthcare Medical Center

    Houston 4699066, Texas 4736286 77004
    United States

    Active - Recruiting

  • The University of Texas Health Science Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • The Heart Hospital Baylor Plano

    Plano 4719457, Texas 4736286 75093
    United States

    Active - Recruiting

  • Methodist Hospital of San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Kaiser Mid Atlantic

    McLean, Virginia 22102
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Kaiser Mid Atlantic

    McLean 4772354, Virginia 6254928 22102
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98112
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98112
    United States

    Active - Recruiting

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