Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
← catalyst calendarNCT04097145 · readout in 499 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,270estimated
Sites
79
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 | 2019-12-11 | actual | When the study began enrolling |
| Primary completion | 2027-12-31 | 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 | 2019-09-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Tricuspid Regurgitation
- Tricuspid Valve Insufficiency
- Tricuspid Valve Disease
Interventions
- Device: Edwards PASCAL System — also filed as Transcatheter tricuspid valve repair (TTVr)
- Drug: Optimal Medical Therapy
- Device: Edwards PASCAL System
- Device: Edwards PASCAL System
Primary outcome
what the primary-completion date above is the date OFComposite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
measured 6 months
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