TRISCEND JAPAN Trial

Edwards EWJ-202 transcatheter tricuspid valve replacement system: Investigation of safety and clinical efficacy using a novel device in patients with at least severe tricuspid regurgitation in Japan - TRISCEND JAPAN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2022220045

Enrollment

Registered

2023-03-07

Start date

2023-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe or greater TR

Interventions

Transcatheter Tricuspid Replacement Therapy using EWJ-202

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Symptomatic Tricuspid Regurgitation (TR) despite medical therapy - Tricuspid Regurgitation graded as severe or greater - Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion criteria

Exclusion criteria: - Tricuspid valve anatomic contraindications - Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months - Hemodynamic instability - Refractory heart failure requiring advanced intervention - Currently participating in another investigational study

Design outcomes

Primary

Measure	Time frame
Two co-primary endpoints - All-cause mortality (1-year post procedure) - Heart failure hospitalization (1-year post procedure)	—

Contacts

Public ContactReiko Masui

Edwards Lifesciences Japan LLC

Reiko_Masui@edwards.com+81-3-6895-0301

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026