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Managing moderate aortic stenosis with TAVR or clinical surveillance

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

NA · Edwards Lifesciences · NCT04889872

This study is testing whether a new heart valve replacement method called TAVR is safer and more effective than just monitoring people with moderate aortic stenosis.

Quick facts

PhaseNA
Study typeInterventional
Enrollment2250 (estimated)
Ages65 Years and up
SexAll
SponsorEdwards Lifesciences (industry)
Locations80 sites (Huntsville, Alabama and 79 other locations)
Trial IDNCT04889872 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valve systems in patients with moderate, calcific aortic stenosis. Participants will be randomly assigned to receive either transcatheter aortic valve replacement (TAVR) or undergo clinical surveillance. The study is designed as a prospective, randomized, controlled, multicenter trial to gather comprehensive data on outcomes associated with each approach.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 65 and older with moderate aortic stenosis who exhibit symptoms or evidence of cardiac dysfunction.

Not a fit: Patients with anatomical characteristics unsuitable for TAVR or those with severe aortic regurgitation or prior aortic valve interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with moderate aortic stenosis, potentially improving their quality of life and clinical outcomes.

How similar studies have performed: Other studies have shown promising results with TAVR in similar patient populations, indicating that this approach is supported by prior evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Huntsville, Alabama and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortic Stenosis, Calcific, Aortic Valve Stenosis, Transcatheter aortic valve replacement, SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA, Moderate aortic stenosis, Aortic stenosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.