DurAVR™ THV System: EMBARK Study
← catalyst calendarNCT05182307 · readout ≤ 530 d
Sponsored by Anteris Technologies Ltd. (industry) · AVR — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Device feasibility
Enrollment
150estimated
Sites
1
Country
Georgia
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 | 2021-11-15 | actual | When the study began enrolling |
| Primary completion | Jan 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Symptomatic Aortic Stenosis
- Severe Aortic Valve Stenosis
- Aortic Valve Calcification
Intervention
- Device: DurAVR™ THV System
Primary outcomes
what the primary-completion date above is the date OFDurAVR™ prosthetic heart valve implant
measured Immediate post procedure
Hemodynamic performance
measured Immediate post procedure
All-cause mortality
measured 30 days
All-cause mortality
measured 1 year
Myocardial infarction
measured 30 days
Myocardial infarction
measured 1 year
Stroke
measured 30 days
Stroke
measured 1 year
Life-threatening bleeding
measured 30 days
Life-threatening bleeding
measured 1 year
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