TRISCEND II Pivotal Trial
← catalyst calendarSponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
864actual
Sites
62
Countries
Germany, 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 | 2021-04-09 | actual | When the study began enrolling |
| Primary completion | 2025-12-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-06-27 | estimated | The whole study's end, after follow-up |
| First posted | 2020-07-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Tricuspid Valve Regurgitation
- Tricuspid Valve Insufficiency
- Tricuspid Valve Disease
- Heart Valve Diseases
- Cardiovascular Diseases
- Heart Failure
Interventions
- Device: Edwards EVOQUE System — also filed as Transcatheter tricuspid valve replacement
- Drug: Optimal Medical Therapy
Primary outcomes
what the primary-completion date above is the date OFRandomized Cohort: Tricuspid Regurgitation (TR) grade reduction
measured 6 months
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
measured 6 months
Randomized Cohort: Rate of Major Adverse Events (MAE)
measured 30 days
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement
measured 1 year
Continued Access Study: Rate of Major Adverse Events (MAE)
measured 30 days
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace
measured 6 months
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
measured 6 months
Continued Access Study: New York Heart Association (NYHA) functional class
measured 6 months
Continued Access Study: 6MWD
measured 6 months
Continued Access Study: All-cause mortality
measured 1 year
Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant
measured 1 year
Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention
measured 1 year
Continued Access Study: Annualized rate of heart failure hospitalizations
measured 1 year
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
measured 1 year
Continued Access Study: New York Heart Association (NYHA) functional class
measured 1 year
Continued Access Study: 6MWD
measured 1 year
Publications
- PMID 39480380 — linked by the registry
- PMID 39475399 — linked by the registry
- PMID 35272771 — linked by the registry
- PMID 34112461 — 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