ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
← catalyst calendarNCT05686317 · readout in 74 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
100estimated
Sites
25
Countries
Brazil, Canada, Germany +2
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 | 2023-04-01 | actual | When the study began enrolling |
| Primary completion | 2026-11-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-01-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Heart Failure
Interventions
- Device: Edwards APTURE transcatheter shunt system
- Diagnostic test: Sham procedure
Primary outcomes
what the primary-completion date above is the date OFDevice + Medical Therapy: Subjects with Early Major Adverse Events
measured 30 days
Mean change in PCWL from baseline at 6 months
measured 6-months
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