PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (NCT04889872) | Clinical Trial Compass
RecruitingNot Applicable
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
United States, Australia, Canada2,250 participantsStarted 2021-10-12
Plain-language summary
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
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing routine clinical surveillance against TAVR for moderate aortic stenosis — given where my condition stands right now, does my doctor think watchful waiting or moving toward a procedure like TAVR is more appropriate for me, and how does this trial's design help answer that question?
2Since this study is listed as Phase NA, which often applies to device or procedure trials rather than drug trials, can my doctor explain what is already known about the safety of TAVR in moderate aortic stenosis specifically, versus the more established use of TAVR in severe cases?
3The trial is measuring both a primary effectiveness endpoint and a primary safety endpoint — can my doctor walk me through what kinds of risks and benefits they would be tracking for me if I were to participate, and how those compare to simply being monitored outside of a trial?
4If I join the surveillance arm of this trial rather than the TAVR arm, what does that monitoring schedule actually look like in terms of visits, tests, and time commitment, and is that realistic given my daily life?
5Are there standard-of-care options available to me right now for moderate aortic stenosis that I should consider before deciding whether enrolling in this trial makes sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.