NCT04889872 · Edwards Lifesciences
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
(PROGRESS)
What this study 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.
View original scientific 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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Key
Exclusion criteria
- 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
- Prior balloon aortic valvuloplasty to treat severe AS
- LVEF \< 20%
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Where
- Huntsville, Alabama
- Tucson, Arizona
- Los Angeles, California
- Pasadena, California
- Rancho Mirage, California
- San Francisco, California
- Santa Barbara, California
- Stanford, California
- Loveland, Colorado
- New Haven, Connecticut
- Gainesville, Florida
- Jacksonville, Florida
And 43 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations