臨床研究等提出・公開システム

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)

TRISCEND JAPAN Trial (TRISCEND JAPAN)

Morino Yoshihiro

Iwate Medical University Hospital

2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture

ymorino@iwate-med.ac.jp

Masui Reiko

Edwards Lifesciences Japan LLC

Shinjuku Front Tower 2-21-1, Kita-Shinjuku, Shinjuku-ku, Tokyo

+81-3-6895-0301

Reiko_Masui@edwards.com

Not Recruiting

Mar. 25, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

Severe or greater TR

Transcatheter Tricuspid Replacement Therapy using EWJ-202

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

Nov. 17, 2022

No

none