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RECRUITING
NCT04889872
NA

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

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

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.

Official title: The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2250

Start Date

2021-10-12

Completion Date

2037-06

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DEVICE

SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

Locations (80)

Heart Center LLC, Huntsville

Huntsville, Alabama, United States

Tucson Medical Center

Tucson, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Huntington Hospital

Pasadena, California, United States

Eisenhower Desert Cardiology Center

Rancho Mirage, California, United States

Bay Area Structural Heart at Sutter Health

San Francisco, California, United States

Kaiser San Francisco Medical Center

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Stanford Univeristy

Stanford, California, United States

UC Health Medical Center of the Rockies

Loveland, Colorado, United States

Yale Universtiy

New Haven, Connecticut, United States

The Cardiac & Vascular Institute Research Foundation

Gainesville, Florida, United States

Baptist Health Research Center

Jacksonville, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Emory University Atlanta

Atlanta, Georgia, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Saint Alphonsus

Boise, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Alexian Brothers Hospital

Lisle, Illinois, United States

Ascension Via Christi St. Francis

Wichita, Kansas, United States

Louisiana State University

New Orleans, Louisiana, United States

Ochsner Clinical Foundation

New Orleans, Louisiana, United States

Massachusetts General Hospital Boston

Boston, Massachusetts, United States

Minneapolis Heart Institue, St. Paul's

Minneapolis, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri, United States

St. Patrick Hospital

Missoula, Montana, United States

Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, United States

Atlantic Health System Hospital Corp - Morristown Medical Center

Morristown, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

University of Buffalo Kaleida Health

Buffalo, New York, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center/NYPH

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Moses Cone Memorial Hospital

Greensboro, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Mount Carmel Health System

Columbus, Ohio, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Kaiser Permanente Northwest

Clackamas, Oregon, United States

Providence Heart & Vascular Institute Portland

Portland, Oregon, United States

Legacy Emanuel Medical Center

Portland, Oregon, United States

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Pinnacle Health Harrisburg

Wormleysburg, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Baptist Memorial Hospital Memphis

Germantown, Tennessee, United States

Methodist Le Bonheur Healthcare

Germantown, Tennessee, United States

Parkwest Medical Center

Knoxville, Tennessee, United States

Saint Thomas Health

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Ascension Texas Cardiovascular

Austin, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

The University of Texas Health Science Center

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Methodist Hospital of San Antonio

San Antonio, Texas, United States

Kaiser Mid Atlantic

McLean, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

The Prince Charles Hospital

Chermside, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

St. Paul's Hospital

Vancouver, British Columbia, Canada

Hamiton Health Services

Hamilton, Onterio, Canada

Kokura Memorial Hospital

Fukuoka, Kyushu, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Keio University Hospital

Shinjuku, Tokyo, Japan

AMC Amsterdam

Amsterdam, North Holland, Netherlands

Leiden Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Erasmus Rotterdam

Rotterdam, South Holland, Netherlands

Hôpitaux Universitaire de Genève

Geneva, Switzerland

Universitätsspital Zürich

Zurich, Switzerland