TRISCEND JAPAN Study

Not Applicable

Active, not recruiting

• Conditions: Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases
• Interventions: Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System

• Registration Number: NCT05760989
• Lead Sponsor: Edwards Lifesciences

Brief Summary

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-06
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Symptomatic tricuspid regurgitation (TR) despite medical therapy
• TR graded as severe or greater
• Appropriate for transcatheter tricuspid valve replacement per the local heart team

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System	Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System	-

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	1 year	Participants with all-cause mortality at 1 year from the index procedure
Heart Failure Hospitalization	1 year	Participants with a heart failure hospitalization at 1 year from the index procedure

Secondary Outcome Measures

Name	Time	Method
New York Heart Association (NYHA) Functional Class	30 days, 6 months, 12 months, annual for five years	Number of participants with improvement in NYHA class
Health Status as measured by the SF-36 Questionnaire	30 days, 6 months, 12 months, annual for five years	Number of points of improvement in health status as measured by 36-item short form survey (SF-36)
Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	30 days, 6 months, 12 months, annual for five years	Number of points of improvement in health status as measured by KCCQ
Rates of various adverse events	30 days, 6 months, 12 months, annual for five years	Rates of various adverse events as defined in the protocol
Rate of Major Adverse Events (MAEs)	30 days	Composite rate of MAEs as defined in the protocol
Reduction in TR grade	30 days, 6 months, 12 months, annual for five years	Number of participants with reduction in TR from baseline
Health Status as measured by the EQ-5D-5L Questionnaire	30 days, 6 months, 12 months, annual for five years	Number of points of improvement in health status as measured by EQ-5D-5L Questionnaire
Six-minute walk test	30 days, 6 months, 12 months, annual for five years	Change in distance (m) from baseline

Trial Locations

Locations (8)

Kokura Memorial Hospital; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Osaka Keisatsu Hospital; 🇯🇵 Osaka-shi, Osaka, Japan

Tokai University Hospital; 🇯🇵 Isehara-shi, Kanagawa, Japan

Sendai Kousei Hospital; 🇯🇵 Sendai-shi, Miyagi, Japan

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

National Cerebral and Cardiovascular Center; 🇯🇵 Suita-shi, Osaka, Japan

Tokyo Women's Medical University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan