ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
← catalyst calendarSponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,948actual
Sites
75
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 | 2019-06-10 | actual | When the study began enrolling |
| Primary completion | 2024-06-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2018-11-08 | actual | When this record first appeared on the registry |
| Results posted | 2025-04-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Aortic Stenosis
Interventions
- Device: ACURATE neo2™ Transfemoral TAVR System
- Device: Medtronic CoreValve TAVR System
- Device: Edwards SAPIEN 3 TAVR System
- Device: ACURATE Prime™ Transfemoral TAVR System XL
Primary outcome
what the primary-completion date above is the date OFComposite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.
measured Participants will be followed for the duration of hospital stay through 1 year.
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-01-20 · 2.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-09-15 · 1.1 MB · SAP_002.pdf
Publications
- PMID 40412426 — reports results
- PMID 40406945 — cited as background
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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