Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
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Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
71actual
Sites
15
Country
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 | 2018-07-31 | actual | When the study began enrolling |
| Primary completion | 2023-12-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2018-05-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-19 | 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
Intervention
- Device: Transcatheter Atrial Shunt System
Primary outcome
what the primary-completion date above is the date OFRate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
measured 30 days
Publications
- PMID 40019407 — 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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