PROGRESS: Management of Moderate Aortic Stenosis
This study, called PROGRESS, is looking at how to best manage moderate aortic stenosis (a narrowing of the heart's aortic valve). It's testing two approaches: either receiving a SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra RESILIA heart valve through a procedure called TAVR (Transcatheter Aortic Valve Replacement), or continuing with clinical surveillance (regular check-ups without the TAVR procedure). You might be able to join if you are 65 or older, have moderate aortic stenosis, and are experiencing symptoms or heart damage. The study will look at the effectiveness of these treatments after two years and safety after 30 days. The current recruitment status is unclear, but the study plans to enroll 2250 participants.
- Study design
- This is a prospective, randomized, controlled study involving multiple centers. Participants will be randomly assigned to either the TAVR procedure or clinical surveillance.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure effectiveness at 2 years and safety at 30 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
At a glance
Conditions
Where it's being run
80 sites across 38 statesStudy leadership
- Philippe Généreux, MD · PRINCIPAL_INVESTIGATOR · Morristown Medical Center, Morristown, NJ, USA
- Jeroen J Bax, MD, PhD · PRINCIPAL_INVESTIGATOR · Leiden University Medical Center, Leiden, The Netherlands
- Raj Makkar, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center, Los Angeles, CA, USA
Who to contact
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What this trial measures
- Primary Effectiveness Endpoint2 years
Non-hierarchical composite of death, and heart failure hospitalization or event
- Primary Safety Endpoint30 days
Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention