An interventional study of SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA in Aortic Stenosis, Calcific and Aortic Valve Stenosis, sponsored by Edwards Lifesciences. Recruiting at 80 sites in 6 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 2,250 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Edwards Lifesciences is the lead sponsor of 124 studies on the registry; 19 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 32 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Transcatheter Aortic Valve Replacement (TAVR)
Device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Clinical Surveillance (CS)
Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve
Primary Effectiveness Endpoint
Non-hierarchical composite of death, and heart failure hospitalization or event
Time frame: 2 years
Primary Safety Endpoint
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
Time frame: 30 days
Death, stroke, or heart failure hospitalization
The number of patients that had this event
Time frame: 2 years
Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years
The number of patients that met all these criteria
Time frame: 2 years
Heart failure hospitalization
The number of patients that had this event
Time frame: 2 years
Left ventricle (LV) mass index
Echocardiographic measurement of the size of the left ventricle
Time frame: 2 years
Diastolic dysfunction ≥ Grade 2
Echocardiographic measurement of the stiffness of the left ventricle.
Time frame: 2 years
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Aortic Valve, Calcification of
Edwards Lifesciences