PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Key facts
- Where
- Hamilton and Vancouver, CanadaSee the 2 sites
Where in Canada
- Hamiton Health ServicesHamilton, CanadaContact: Edwards THV Clinical AffairsNo longer taking part
- St. Paul's HospitalVancouver, CanadaContact: Edwards THV Clinical AffairsNo longer taking part
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 doctorTrial details
- Who runs it
- Edwards Lifesciences
- Trial code
- NCT04889872
- Record updated
- 17 December 2025
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.