PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Treatment groups
2,250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov