TRISCEND JAPAN Trial

JRCT ID: jRCT2022220045

Registered date:07/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe or greater TR
• Date of first enrollment: 25/03/2023
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Transcatheter Tricuspid Replacement Therapy using EWJ-202

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Morino Yoshihiro