PROGRESS
The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Sponsor study identifier
interventional
2,250
6 countries
80
Study Start
October 12, 2021
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2021
Actual (reported)May 17, 2021
Actual (reported)October 12, 2021
Actual (reported)June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Death, stroke, or heart failure hospitalization
2 years
Transcatheter Aortic Valve Replacement (TAVR)
Clinical Surveillance (CS)
Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Genereux P, Makkar RR, Bax JJ, Pibarot P, Lindman BR, Prince H, Park B, Cohen DJ, Mack MJ, Leon MB. Design and rationale of the prospective, randomized, controlled trial to assess the management of moderate aortic stenosis by clinical surveillance or transcatheter aortic valve replacement: The PROGRESS Trial. Am Heart J. 2026 Jul;297:107433. doi: 10.1016/j.ahj.2026.107433. Epub 2026 Mar 25.
Philippe Généreux, MD
Morristown Medical Center, Morristown, NJ, USA
Jeroen J Bax, MD, PhD
Leiden University Medical Center, Leiden, The Netherlands
Raj Makkar, MD
Cedars-Sinai Medical Center, Los Angeles, CA, USA
First Submitted
May 12, 2021
First Posted
May 17, 2021
Study Start
October 12, 2021
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years
2 years
Heart failure hospitalization
2 years
Left ventricle (LV) mass index
2 years
Diastolic dysfunction ≥ Grade 2
2 years
Contact the study team to confirm eligibility.
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
Study Completion
June 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 17, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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