Clinical Study of Edwards Cardioband FIT Valve Repair System
← catalyst calendarNCT03382457 · readout in 134 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
75estimated
Sites
9
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 | 2018-07-01 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2017-12-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Tricuspid Regurgitation
Intervention
- Device: Transcatheter Tricuspid Valve Repair — also filed as Edwards Cardioband Tricuspid Valve Repair
Primary outcomes
what the primary-completion date above is the date OFPrimary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
measured 30 days
Primary Performance Endpoint - Intraprocedural Success
measured Intraprocedural
Primary Performance Endpoint - Clinical Success
measured 30 days and 1 year
Publications
- PMID 33744150 — linked by the registry
- PMID 33413863 — 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.
Permalink · EW's whole pipeline · Catalyst calendar · Every registered study · What changed