Actively Recruiting
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Led by Edwards Lifesciences · Updated on 2025-12-17
2250
Participants Needed
80
Research Sites
815 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 65 years of age or older at time of randomization
- Moderate aortic stenosis
- Symptoms or evidence of cardiac damage or dysfunction
- Written informed consent provided by the subject or legal representative
You will not qualify if you...
- Native aortic annulus size unsuitable for the transcatheter heart valve
- Anatomical features preventing safe transfemoral placement or delivery system passage
- Unicuspid or non-calcified aortic valve
- Bicuspid aortic valve with an aneurysmal ascending aorta larger than 4.5 cm or severe raphe/leaflet calcification
- Existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
- Prior balloon aortic valvuloplasty for severe aortic stenosis
- Left ventricular ejection fraction less than 20%
- Left ventricular outflow tract calcification increasing risk of annular rupture or significant leak after TAVR
- Cardiac imaging showing intracardiac mass, thrombus, or vegetation
- Coronary or aortic valve anatomy increasing risk of coronary artery obstruction after TAVR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 80 locations
1
Heart Center LLC, Huntsville
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
Tucson Medical Center
Tucson, Arizona, United States, 85712
Active, Not Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Huntington Hospital
Pasadena, California, United States, 91105
Withdrawn
5
Eisenhower Desert Cardiology Center
Rancho Mirage, California, United States, 92270
Actively Recruiting
6
Bay Area Structural Heart at Sutter Health
San Francisco, California, United States, 94109
Actively Recruiting
7
Kaiser San Francisco Medical Center
San Francisco, California, United States, 94118
Active, Not Recruiting
8
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
9
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Actively Recruiting
10
Stanford Univeristy
Stanford, California, United States, 94305
Actively Recruiting
11
UC Health Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
12
Yale Universtiy
New Haven, Connecticut, United States, 06510
Actively Recruiting
13
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605
Withdrawn
14
Baptist Health Research Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
15
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
16
Emory University Atlanta
Atlanta, Georgia, United States, 30308
Actively Recruiting
17
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
18
Saint Alphonsus
Boise, Idaho, United States, 83704
Actively Recruiting
19
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
20
Alexian Brothers Hospital
Lisle, Illinois, United States, 60532
Actively Recruiting
21
Ascension Via Christi St. Francis
Wichita, Kansas, United States, 67226
Actively Recruiting
22
Louisiana State University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
23
Ochsner Clinical Foundation
New Orleans, Louisiana, United States, 70121
Active, Not Recruiting
24
Massachusetts General Hospital Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Minneapolis Heart Institue, St. Paul's
Minneapolis, Minnesota, United States, 55102
Actively Recruiting
26
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
27
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States, 64111
Actively Recruiting
28
St. Patrick Hospital
Missoula, Montana, United States, 59802
Active, Not Recruiting
29
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
30
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
31
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
32
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
33
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
34
University of Buffalo Kaleida Health
Buffalo, New York, United States, 14203
Actively Recruiting
35
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
36
NYU Langone Health
New York, New York, United States, 10016
Withdrawn
37
Columbia University Irving Medical Center/NYPH
New York, New York, United States, 10032
Active, Not Recruiting
38
Rochester General Hospital
Rochester, New York, United States, 14621
Actively Recruiting
39
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
40
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
41
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Actively Recruiting
42
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Active, Not Recruiting
43
Mount Carmel Health System
Columbus, Ohio, United States, 43213
Active, Not Recruiting
44
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
45
Kaiser Permanente Northwest
Clackamas, Oregon, United States, 97015
Active, Not Recruiting
46
Providence Heart & Vascular Institute Portland
Portland, Oregon, United States, 97225
Withdrawn
47
Legacy Emanuel Medical Center
Portland, Oregon, United States, 97227
Actively Recruiting
48
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
49
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15213
Active, Not Recruiting
50
Pinnacle Health Harrisburg
Wormleysburg, Pennsylvania, United States, 17043
Active, Not Recruiting
51
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
52
Baptist Memorial Hospital Memphis
Germantown, Tennessee, United States, 38138
Actively Recruiting
53
Methodist Le Bonheur Healthcare
Germantown, Tennessee, United States, 38138
Actively Recruiting
54
Parkwest Medical Center
Knoxville, Tennessee, United States, 37923
Actively Recruiting
55
Saint Thomas Health
Nashville, Tennessee, United States, 37205
Actively Recruiting
56
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
57
Ascension Texas Cardiovascular
Austin, Texas, United States, 78705
Actively Recruiting
58
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
59
HCA Houston Healthcare Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
60
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Actively Recruiting
61
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
62
Methodist Hospital of San Antonio
San Antonio, Texas, United States, 78229
Active, Not Recruiting
63
Kaiser Mid Atlantic
McLean, Virginia, United States, 22102
Actively Recruiting
64
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
65
Swedish Medical Center
Seattle, Washington, United States, 98112
Actively Recruiting
66
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Active, Not Recruiting
67
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Active, Not Recruiting
68
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Active, Not Recruiting
69
Monash Health
Clayton, Victoria, Australia, 3168
Active, Not Recruiting
70
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6E1M7
Active, Not Recruiting
71
Hamiton Health Services
Hamilton, Onterio, Canada, L8L 2X2
Active, Not Recruiting
72
Kokura Memorial Hospital
Fukuoka, Kyushu, Japan, 802-8555
Active, Not Recruiting
73
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 981-0914
Active, Not Recruiting
74
Sakakibara Heart Institute
Fuchū, Tokyo, Japan, 183-0003
Active, Not Recruiting
75
Keio University Hospital
Shinjuku, Tokyo, Japan, 160-8582
Active, Not Recruiting
76
AMC Amsterdam
Amsterdam, North Holland, Netherlands, 1105 AZ
Active, Not Recruiting
77
Leiden Universitair Medisch Centrum
Leiden, South Holland, Netherlands, 2333
Active, Not Recruiting
78
Erasmus Rotterdam
Rotterdam, South Holland, Netherlands, 3015
Active, Not Recruiting
79
Hôpitaux Universitaire de Genève
Geneva, Switzerland, 1205
Active, Not Recruiting
80
Universitätsspital Zürich
Zurich, Switzerland, 8091
Withdrawn
Research Team
E
Edwards THV Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here