PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
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
Interventions
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Conditions
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