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Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

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NCT04614402

Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.

Phase
Status
Active, not recruiting
Study type
Observational
Enrollment
300estimated
Sites
15
Countries
Germany, Greece, Italy +1

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
DateFiledBasisWhat it is
Start2021-01-15actualWhen the study began enrolling
Primary completion2023-04-20actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2028-03-15estimatedThe whole study's end, after follow-up
First posted2020-11-04actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-16actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Tricuspid Valve Insufficiency

Interventions

  • Device: Edwards PASCAL Transcatheter Valve Repair System
  • Device: Edwards PASCAL Precision Transcatheter Valve Repair System

Primary outcomes

what the primary-completion date above is the date OF
Number of patients with major adverse events (MAE rates)
measured 30 days
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
measured Discharge: defined as discharge or 7 days post-procedure, whichever comes first

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