EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
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Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
901actual
Sites
77
Countries
Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-07-12 | actual | When the study began enrolling |
| Primary completion | 2024-03-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2017-02-03 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-05-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Heart Diseases
- Aortic Stenosis, Severe
Intervention
- Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV — also filed as SAPIEN 3, SAPIEN 3 Ultra
Primary outcome
what the primary-completion date above is the date OFAll-cause death, all stroke, and unplanned cardiovascular hospitalization
measured When all patients have reached 2-year follow-up
Publications
- PMID 42485012 — linked by the registry
- PMID 42233211 — linked by the registry
- PMID 41297989 — linked by the registry
- PMID 41128701 — linked by the registry
- PMID 40163596 — linked by the registry
- PMID 39466903 — linked by the registry
- PMID 38056546 — linked by the registry
- PMID 32774184 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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