Frontlight ResearchEarly access
Taking people in United StatesNo phase
Heart valve replacement versus watchful monitoring for moderate aortic stenosis
Compares a transcatheter heart valve with monitoring in people with moderate calcific aortic stenosis.
Key facts
- Who runs it
- Edwards Lifesciences
- Where
- Atlanta, Austin, Boise, Boston, Buffalo, Chicago, Cincinnati, Clackamas, Columbus, Dallas, Gainesville, Germantown, Greensboro, Houston, Huntsville, Jacksonville, Kansas City, Knoxville, Lebanon, Lisle, Los Angeles, Loveland, McLean, Mineola, Minneapolis, Missoula, Morristown, Nashville, Neptune City, New Brunswick, New Haven, New Orleans, New York, Norfolk, Pasadena, Pittsburgh, Plano, Portland, Rancho Mirage, Ridgewood, Rochester, Roslyn, Saint Cloud, San Antonio, San Francisco, Santa Barbara, Sarasota, Seattle, Stanford, The Bronx, Tucson, Tulsa, Wichita, Wormleysburg, and Wynnewood, United StatesSee the 65 sitesAlso in 5 other countries, 15 sites
- Trial code
- Registry title
- PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
- Status
- Recruiting
- People taking part
- 2,250 people, planned
- Started
- 12 Oct 2021
- Expected to end
- Jun 2037
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Record updated
- 17 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 65 or older with moderate aortic stenosis, a narrowing of the heart's main valve caused by calcium. They must have symptoms or signs of heart damage. Participants get either a new valve placed through a tube (TAVR) or regular check-ups.
- Age
- 65 years or older
- Sex
- All sexes
- Disease stage
- Moderate, calcific aortic stenosis, with symptoms or evidence of heart damage or poor heart function.
- Earlier treatment
- People who had a balloon procedure to widen the aortic valve for severe aortic stenosis cannot join. People who already have a mechanical or tissue replacement aortic valve cannot join.
Main reasons for not taking part
- Valve ring size or blood vessels that do not allow the device to be placed safely through the groin
- Aortic valve with one flap or without calcium
- Severe leaking of the aortic valve
- Heart pumping strength (LVEF) below 20%
- A mass, blood clot or growth inside the heart seen on imaging
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 65 years of age or older at time of randomization
- Moderate aortic stenosis
- Subject has symptoms or evidence of cardiac damage/dysfunction
- 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
Who cannot take part
- Prior balloon aortic valvuloplasty to treat severe AS
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- LVEF < 20%
- Native aortic annulus size unsuitable for the THV
- Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid or non-calcified
- Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
- Pre-existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
- Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Where in United States
Also in 5 other countries, 15 sites
- Emory University AtlantaAtlanta, United StatesContact: Edwards THV Clinical AffairsTaking people
- Piedmont Heart InstituteAtlanta, United StatesContact: Edwards THV Clinical AffairsTaking people
- Ascension Texas CardiovascularAustin, United StatesContact: Edwards THV Clinical AffairsTaking people
- Saint AlphonsusBoise, United StatesContact: Edwards THV Clinical AffairsTaking people
- Massachusetts General Hospital - BostonBoston, United StatesContact: Edwards THV Clinical AffairsTaking people
- University of Buffalo / Kaleida HealthBuffalo, United StatesContact: Edwards THV Clinical AffairsTaking people
- Rush University Medical CenterChicago, United StatesContact: Edwards THV Clinical AffairsTaking people
- The Christ HospitalCincinnati, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Kaiser Permanente NorthwestClackamas, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Mount Carmel Health SystemColumbus, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- UT Southwestern Medical CenterDallas, United StatesContact: Edwards THV Clinical AffairsTaking people
- The Cardiac & Vascular Institute Research FoundationGainesville, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Baptist Memorial Hospital MemphisGermantown, United StatesContact: Edwards THV Clinical AffairsTaking people
- Methodist Le Bonheur HealthcareGermantown, United StatesContact: Edwards THV Clinical AffairsTaking people
- Moses Cone Memorial HospitalGreensboro, United StatesContact: Edwards THV Clinical AffairsTaking people
- HCA Houston Healthcare Medical CenterHouston, United StatesContact: Edwards THV Clinical AffairsTaking people
- The University of Texas Health Science CenterHouston, United StatesContact: Edwards THV Clinical AffairsTaking people
- Heart Center LLC, HuntsvilleHuntsville, United StatesContact: Edwards THV Clinical AffairsTaking people
- Baptist Health Research CenterJacksonville, United StatesContact: Edwards THV Clinical AffairsTaking people
- Saint Luke's Hospital of Kansas City Mid AmericaKansas City, United StatesContact: Edwards THV Clinical AffairsTaking people
- Parkwest Medical CenterKnoxville, United StatesContact: Edwards THV Clinical AffairsTaking people
- Mary Hitchcock Memorial HospitalLebanon, United StatesContact: Edwards THV Clinical AffairsTaking people
- Alexian Brothers HospitalLisle, United StatesContact: Edwards THV Clinical AffairsTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Edwards THV Clinical AffairsTaking people
- UC Health Medical Center of the RockiesLoveland, United StatesContact: Edwards THV Clinical AffairsTaking people
- Kaiser Mid AtlanticMcLean, United StatesContact: Edwards THV Clinical AffairsTaking people
- NYU Langone Hospital - Long IslandMineola, United StatesContact: Edwards THV Clinical AffairsTaking people
- Minneapolis Heart Institue, St. Paul'sMinneapolis, United StatesContact: Edwards THV Clinical AffairsTaking people
- St. Patrick HospitalMissoula, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Atlantic Health System Hospital Corp - Morristown Medical CenterMorristown, United StatesContact: Edwards THV Clinical AffairsTaking people
- Saint Thomas HealthNashville, United StatesContact: Edwards THV Clinical AffairsTaking people
- Vanderbilt University Medical CenterNashville, United StatesContact: Edwards THV Clinical AffairsTaking people
- Jersey Shore University Medical CenterNeptune City, United StatesContact: Edwards THV Clinical AffairsTaking people
- Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesContact: Edwards THV Clinical AffairsTaking people
- Yale UniverstiyNew Haven, United StatesContact: Edwards THV Clinical AffairsTaking people
- Louisiana State UniversityNew Orleans, United StatesContact: Edwards THV Clinical AffairsTaking people
- Ochsner Clinical FoundationNew Orleans, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Columbia University Irving Medical Center/NYPHNew York, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- NYU Langone HealthNew York, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Sentara Norfolk General HospitalNorfolk, United StatesContact: Edwards THV Clinical AffairsTaking people
- Huntington HospitalPasadena, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Allegheny-Singer Research InstitutePittsburgh, United StatesContact: Edwards THV Clinical AffairsTaking people
- UPMC Presbyterian ShadysidePittsburgh, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- The Heart Hospital Baylor PlanoPlano, United StatesContact: Edwards THV Clinical AffairsTaking people
- Legacy Emanuel Medical CenterPortland, United StatesContact: Edwards THV Clinical AffairsTaking people
- Providence Heart & Vascular Institute PortlandPortland, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Eisenhower Desert Cardiology CenterRancho Mirage, United StatesContact: Edwards THV Clinical AffairsTaking people
- The Valley HospitalRidgewood, United StatesContact: Edwards THV Clinical AffairsTaking people
- Rochester General HospitalRochester, United StatesContact: Edwards THV Clinical AffairsTaking people
- St. Francis HospitalRoslyn, United StatesContact: Edwards THV Clinical AffairsTaking people
- Centracare Heart and Vascular CenterSaint Cloud, United StatesContact: Edwards THV Clinical AffairsTaking people
- Methodist Hospital of San AntonioSan Antonio, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Bay Area Structural Heart at Sutter HealthSan Francisco, United StatesContact: Edwards THV Clinical AffairsTaking people
- University of California San FranciscoSan Francisco, United StatesContact: Edwards THV Clinical AffairsTaking people
- Kaiser San Francisco Medical CenterSan Francisco, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Santa Barbara Cottage HospitalSanta Barbara, United StatesContact: Edwards THV Clinical AffairsTaking people
- Sarasota Memorial Health Care SystemSarasota, United StatesContact: Edwards THV Clinical AffairsTaking people
- Swedish Medical CenterSeattle, United StatesContact: Edwards THV Clinical AffairsTaking people
- Stanford UniveristyStanford, United StatesContact: Edwards THV Clinical AffairsTaking people
- Montefiore Medical CenterThe Bronx, United StatesContact: Edwards THV Clinical AffairsTaking people
- Tucson Medical CenterTucson, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Oklahoma Heart InstituteTulsa, United StatesContact: Edwards THV Clinical AffairsTaking people
- Ascension Via Christi St. FrancisWichita, United StatesContact: Edwards THV Clinical AffairsTaking people
- Pinnacle Health HarrisburgWormleysburg, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesContact: Edwards THV Clinical AffairsTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
The 2 groups in the trial
- TAVRTreatment being tested
Transcatheter Aortic Valve Replacement (TAVR)
Treatment: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- CSNo study treatment, for comparison
Clinical Surveillance (CS)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
- Plain-language title
- Heart valve replacement versus watchful monitoring for moderate aortic stenosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Publications
- TAVR in Patients with Moderate Aortic Stenosis with At-Risk Features.The New England journal of medicine, 2026
- 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.American heart journal, 2026
- Record updated
- 17 December 2025