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NCT04889872NARecruiting

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

Edwards Lifesciences

Start Date

10/12/2021

Completion Date

6/1/2037

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.

Detailed 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.

Eligibility Criteria

Age Range: 65 years to No maximum

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 the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer 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 severe raphe/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 annular rupture 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 artery obstruction post-TAVR

Interventions

DEVICE

SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Aortic Stenosis, CalcificAortic Valve Stenosis

Locations

Heart Center LLC, Huntsville

Huntsville, Alabama 35801

United States

Tucson Medical Center

Tucson, Arizona 85712

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Huntington Hospital

Pasadena, California 91105

United States

Eisenhower Desert Cardiology Center

Rancho Mirage, California 92270

United States

Bay Area Structural Heart at Sutter Health

San Francisco, California 94109

United States

Kaiser San Francisco Medical Center

San Francisco, California 94118

United States

University of California San Francisco

San Francisco, California 94143

United States

Santa Barbara Cottage Hospital

Santa Barbara, California 93105

United States

Stanford Univeristy

Stanford, California 94305

United States

UC Health Medical Center of the Rockies

Loveland, Colorado 80538

United States

Yale Universtiy

New Haven, Connecticut 06510

United States

The Cardiac & Vascular Institute Research Foundation

Gainesville, Florida 32605

United States

Baptist Health Research Center

Jacksonville, Florida 32207

United States

Sarasota Memorial Health Care System

Sarasota, Florida 34239

United States

Emory University Atlanta

Atlanta, Georgia 30308

United States

Piedmont Heart Institute

Atlanta, Georgia 30309

United States

Saint Alphonsus

Boise, Idaho 83704

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Alexian Brothers Hospital

Lisle, Illinois 60532

United States

Ascension Via Christi St. Francis

Wichita, Kansas 67226

United States

Louisiana State University

New Orleans, Louisiana 70112

United States

Ochsner Clinical Foundation

New Orleans, Louisiana 70121

United States

Massachusetts General Hospital Boston

Boston, Massachusetts 02114

United States

Minneapolis Heart Institue, St. Paul's

Minneapolis, Minnesota 55102

United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota 56303

United States

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri 64111

United States

St. Patrick Hospital

Missoula, Montana 59802

United States

Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire 03756

United States

Atlantic Health System Hospital Corp - Morristown Medical Center

Morristown, New Jersey 07960

United States

Jersey Shore University Medical Center

Neptune City, New Jersey 07753

United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey 08901

United States

The Valley Hospital

Ridgewood, New Jersey 07450

United States

University of Buffalo Kaleida Health

Buffalo, New York 14203

United States

NYU Langone Hospital - Long Island

Mineola, New York 11501

United States

NYU Langone Health

New York, New York 10016

United States

Columbia University Irving Medical Center/NYPH

New York, New York 10032

United States

Rochester General Hospital

Rochester, New York 14621

United States

St. Francis Hospital

Roslyn, New York 11576

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Moses Cone Memorial Hospital

Greensboro, North Carolina 27401

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

Mount Carmel Health System

Columbus, Ohio 43213

United States

Oklahoma Heart Institute

Tulsa, Oklahoma 74104

United States

Kaiser Permanente Northwest

Clackamas, Oregon 97015

United States

Providence Heart & Vascular Institute Portland

Portland, Oregon 97225

United States

Legacy Emanuel Medical Center

Portland, Oregon 97227

United States

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania 15212

United States

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania 15213

United States

Pinnacle Health Harrisburg

Wormleysburg, Pennsylvania 17043

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

Baptist Memorial Hospital Memphis

Germantown, Tennessee 38138

United States

Methodist Le Bonheur Healthcare

Germantown, Tennessee 38138

United States

Parkwest Medical Center

Knoxville, Tennessee 37923

United States

Saint Thomas Health

Nashville, Tennessee 37205

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Ascension Texas Cardiovascular

Austin, Texas 78705

United States

UT Southwestern Medical Center

Dallas, Texas 75235

United States

HCA Houston Healthcare Medical Center

Houston, Texas 77004

United States

The University of Texas Health Science Center

Houston, Texas 77030

United States

The Heart Hospital Baylor Plano

Plano, Texas 75093

United States

Methodist Hospital of San Antonio

San Antonio, Texas 78229

United States

Kaiser Mid Atlantic

McLean, Virginia 22102

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Swedish Medical Center

Seattle, Washington 98112

United States

The Prince Charles Hospital

Chermside, Queensland 4032

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

Monash Health

Clayton, Victoria 3168

Australia

St. Paul's Hospital

Vancouver, British Columbia V6E1M7

Canada

Hamiton Health Services

Hamilton, Onterio L8L 2X2

Canada

Kokura Memorial Hospital

Fukuoka, Kyushu 802-8555

Japan

Sendai Kousei Hospital

Sendai, Miyagi 981-0914

Japan

Sakakibara Heart Institute

Fuchū, Tokyo 183-0003

Japan

Keio University Hospital

Shinjuku, Tokyo 160-8582

Japan

AMC Amsterdam

Amsterdam, North Holland 1105 AZ

Netherlands

Leiden Universitair Medisch Centrum

Leiden, South Holland 2333

Netherlands

Erasmus Rotterdam

Rotterdam, South Holland 3015

Netherlands

Hôpitaux Universitaire de Genève

Geneva, 1205

Switzerland

Universitätsspital Zürich

Zurich, 8091

Switzerland