NYU Langone Hospital - Long Island | Dialysis and Nephrology
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About
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.
Full description
This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
2,250 participants in 2 patient groups
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Central trial contact
Edwards THV Clinical Affairs
Data sourced from clinicaltrials.gov
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