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

December 12, 2025 updated by: Edwards Lifesciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Active, not recruiting
        • The Prince Charles Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Active, not recruiting
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Active, not recruiting
        • Monash Health
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E1M7
        • Active, not recruiting
        • St. Paul's Hospital
    • Onterio
      • Hamilton, Onterio, Canada, L8L 2X2
        • Active, not recruiting
        • Hamiton Health Services
  • Japan
    • Kyushu
      • Fukuoka, Kyushu, Japan, 802-8555
        • Active, not recruiting
        • Kokura Memorial Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • Active, not recruiting
        • Sendai Kousei Hospital
    • Tokyo
      • Fuchū, Tokyo, Japan, 183-0003
        • Active, not recruiting
        • Sakakibara Heart Institute
      • Shinjuku, Tokyo, Japan, 160-8582
        • Active, not recruiting
        • Keio University Hospital
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Active, not recruiting
        • AMC Amsterdam
    • South Holland
      • Leiden, South Holland, Netherlands, 2333
        • Active, not recruiting
        • Leiden Universitair Medisch Centrum
      • Rotterdam, South Holland, Netherlands, 3015
        • Active, not recruiting
        • Erasmus Rotterdam
  • Switzerland
      • Geneva, Switzerland, 1205
        • Active, not recruiting
        • Hopitaux Universitaire de Geneve
      • Zurich, Switzerland, 8091
        • Withdrawn
        • Universitatsspital Zurich
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Heart Center LLC, Huntsville
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Active, not recruiting
        • Tucson Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
      • Pasadena, California, United States, 91105
        • Withdrawn
        • Huntington Hospital
      • Rancho Mirage, California, United States, 92270
        • Recruiting
        • Eisenhower Desert Cardiology Center
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
      • San Francisco, California, United States, 94109
        • Recruiting
        • Bay Area Structural Heart at Sutter Health
      • San Francisco, California, United States, 94118
        • Active, not recruiting
        • Kaiser San Francisco Medical Center
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Santa Barbara Cottage Hospital
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Univeristy
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • UC Health Medical Center of the Rockies
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Universtiy
    • Florida
      • Gainesville, Florida, United States, 32605
        • Withdrawn
        • The Cardiac & Vascular Institute Research Foundation
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Research Center
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Health Care System
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Atlanta
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Saint Alphonsus
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Alexian Brothers Hospital
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Ascension Via Christi St. Francis
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University
      • New Orleans, Louisiana, United States, 70121
        • Active, not recruiting
        • Ochsner Clinical Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Boston
    • Minnesota
      • Minneapolis, Minnesota, United States, 55102
        • Recruiting
        • Minneapolis Heart Institue, St. Paul's
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • CentraCare Heart and Vascular Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City Mid America
    • Montana
      • Missoula, Montana, United States, 59802
        • Active, not recruiting
        • St. Patrick Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Mary Hitchcock Memorial Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System Hospital Corp - Morristown Medical Center
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Valley Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University of Buffalo Kaleida Health
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • Withdrawn
        • NYU Langone Health
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Irving Medical Center/NYPH
      • Rochester, New York, United States, 14621
        • Recruiting
        • Rochester General Hospital
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Moses Cone Memorial Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • The Christ Hospital
      • Columbus, Ohio, United States, 43213
        • Active, not recruiting
        • Mount Carmel Health System
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Institute
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Active, not recruiting
        • Kaiser Permanente Northwest
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Legacy Emanuel Medical Center
      • Portland, Oregon, United States, 97225
        • Withdrawn
        • Providence Heart & Vascular Institute Portland
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Singer Research Institute
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • UPMC Presbyterian Shadyside
      • Wormleysburg, Pennsylvania, United States, 17043
        • Active, not recruiting
        • Pinnacle Health Harrisburg
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Methodist Le Bonheur Healthcare
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Baptist Memorial Hospital Memphis
      • Knoxville, Tennessee, United States, 37923
        • Recruiting
        • Parkwest Medical Center
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Saint Thomas Health
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Texas Cardiovascular
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77004
        • Recruiting
        • HCA Houston Healthcare Medical Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center
      • Plano, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Baylor Plano
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Methodist Hospital of San Antonio
    • Virginia
      • McLean, Virginia, United States, 22102
        • Recruiting
        • Kaiser Mid Atlantic
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98112
        • Recruiting
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. 65 years of age or older at time of randomization
  2. Moderate aortic stenosis
  3. Subject has symptoms or evidence of cardiac damage/dysfunction
  4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Key Exclusion Criteria:

  1. Native aortic annulus size unsuitable for the THV
  2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
  3. Aortic valve is unicuspid or non-calcified
  4. Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
  5. Pre-existing mechanical or bioprosthetic aortic valve
  6. Severe aortic regurgitation
  7. Prior balloon aortic valvuloplasty to treat severe AS
  8. LVEF < 20%
  9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
  10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAVR
Transcatheter Aortic Valve Replacement (TAVR)
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
No Intervention: CS
Clinical Surveillance (CS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 2 years
Non-hierarchical composite of death, and heart failure hospitalization or event
2 years
Primary Safety Endpoint
Time Frame: 30 days
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left ventricle (LV) mass index
Time Frame: 2 years
Echocardiographic measurement of the size of the left ventricle
2 years
Diastolic dysfunction ≥ Grade 2
Time Frame: 2 years
Echocardiographic measurement of the stiffness of the left ventricle.
2 years
Death, stroke, or heart failure hospitalization
Time Frame: 2 years
The number of patients that had this event
2 years
Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years
Time Frame: 2 years
The number of patients that met all these criteria
2 years
Heart failure hospitalization
Time Frame: 2 years
The number of patients that had this event
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Généreux, MD, Morristown Medical Center, Morristown, NJ, USA
  • Principal Investigator: Jeroen J Bax, MD, PhD, Leiden University Medical Center, Leiden, The Netherlands
  • Principal Investigator: Raj Makkar, MD, Cedars-Sinai Medical Center, Los Angeles, CA, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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