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2019-06 TRISCEND Study

← catalyst calendar

NCT04221490 · results posted

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

Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
228actual
Sites
20
Countries
Canada, France, Switzerland +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
Start2020-05-06actualWhen the study began enrolling
Primary completion2024-01-05actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-01-31estimatedThe whole study's end, after follow-up
First posted2020-01-09actualWhen this record first appeared on the registry
Results posted2025-01-09actualWhen the sponsor posted results to the registry
Record updated2026-05-08actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Tricuspid Valve Regurgitation
  • Heart Valve Diseases
  • Cardiovascular Diseases

Intervention

  • Device: Transcatheter Tricuspid Valve Replacement — also filed as Edwards EVOQUE Tricuspid Valve Replacement System

Primary outcomes

what the primary-completion date above is the date OF
Composite Major Adverse Events (MAEs)
measured 30 Days
Device Success
measured Intraprocedural
Procedure Success
measured Discharge (Up to 7 days post procedure)
Clinical Success
measured 30 Days
Tricuspid Regurgitation Reduction
measured Discharge (Up to 7 days post procedure)

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2021-05-04 · 24.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-08-01 · 1.0 MB · SAP_001.pdf

Publications

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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