Taking peopleNo phase
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Key facts
- Who runs it
- Edwards Lifesciences
- Where
- Geneva and Zurich, SwitzerlandSee the 2 sitesAlso in 5 other countries, 78 sites
- Trial code
- 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
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
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 Switzerland
Also in 5 other countries, 78 sites
- Hôpitaux Universitaire de GenèveGeneva, SwitzerlandContact: Edwards THV Clinical AffairsNo longer taking part
- Universitätsspital ZürichZurich, SwitzerlandContact: Edwards THV Clinical AffairsNo longer taking part
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
- 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