PROGRESS
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
AI Description
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.
- Who can join
- older adult
- Participants
- 2250
- Expected completion
- 2037-06
- Funded by
- industry
Conditions studied
Aortic Stenosis, Calcific, Aortic Valve Stenosis
What is being tested
- DEVICE: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
What it measures
- Primary Effectiveness Endpoint, Non-hierarchical composite of death, and heart failure hospitalization or event, 2 years
- Primary Safety Endpoint, Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention, 30 days
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Allegheny General Hospital
Pittsburgh, PA
Ascension Saint Thomas Hospital
Nashville, TN
Ascension Seton Medical Center Austin
Austin, TX
Ascension Via Christi (Wichita)
Wichita, KS
Baptist Medical Center Jacksonville
Jacksonville, FL
Baptist Memorial Hospital-Memphis
Memphis, TN
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
California Pacific Medical Center (Van Ness Campus)
San Francisco, CA
Cedars-Sinai Medical Center
Los Angeles, CA
CentraCare – St. Cloud Hospital
Saint Cloud, MN
Dartmouth Hitchcock Medical Center (Lebanon)
Lebanon, NH
Eisenhower Health
Rancho Mirage, CA
Emory University Hospital Midtown
Atlanta, GA
HCA Florida North Florida Hospital
Gainesville, FL
HCA Houston Healthcare Medical Center
Houston, TX
Hillcrest Medical Center
Tulsa, OK
Huntington Hospital
Pasadena, CA
Huntsville Hospital
Huntsville, AL
Jersey Shore University Medical Center
Neptune, NJ
Kaiser Permanente San Francisco Medical Center
San Francisco, CA
Kaleida Health
Buffalo, NY
Lankenau Medical Center
Wynnewood, PA
Legacy Emanuel Medical Center
Portland, OR
Massachusetts General Hospital
Boston, MA
Methodist Hospital
San Antonio, TX
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
Morristown Medical Center
Morristown, NJ
Mount Carmel East
Columbus, OH
NYU Langone Health
New York, NY
Ochsner Medical Center – New Orleans
New Orleans, LA
Parkwest Medical Center
Knoxville, TN
Piedmont Atlanta Hospital
Atlanta, GA
Providence St. Patrick Hospital
Missoula, MT
Providence St. Vincent Medical Center
Portland, OR
Robert Wood Johnson University Hospital
New Brunswick, NJ
Rochester General Hospital
Rochester, NY
Rush University Medical Center
Chicago, IL
Saint Alphonsus Regional Medical Center
Boise, ID
Saint Luke’s Hospital of Kansas City
Kansas City, MO
Santa Barbara Cottage Hospital
Santa Barbara, CA
Sarasota Memorial Hospital
Sarasota, FL
Sentara Norfolk General Hospital
Norfolk, VA
St. Francis Hospital & Heart Center
Roslyn, NY
Stanford Health Care
Stanford, CA
Swedish Cherry Hill Campus
Seattle, WA
The Christ Hospital
Cincinnati, OH
The Moses H. Cone Memorial Hospital
Greensboro, NC
The Valley Hospital
Paramus, NJ
Tucson Medical Center
Tucson, AZ
UCHealth Medical Center of the Rockies
Loveland, CO
UCSF Health
San Francisco, CA
United Hospital (Saint Paul)
Saint Paul, MN
UPMC Harrisburg
Harrisburg, PA
UPMC Presbyterian Shadyside
Pittsburgh, PA
Vanderbilt University Medical Center
Nashville, TN
William P. Clements Jr. University Hospital
Dallas, TX
Yale New Haven Hospital
New Haven, CT
Registry entry updated 2025-12-17
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.