TRISCEND JAPAN Study

Cardiovascular Diseases Clinical Trial

— TRISCEND JAPAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760989
• Other study ID #: 2021-12
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: April 30, 2029

Study information

• Verified date: February 2024
• Source: Edwards Lifesciences
• Contact: Aya Saeki
• Phone: 03-6894-0500
• Email: Aya_Saeki[@]edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 30, 2029
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Valve Diseases
• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Device:
• Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Replacement of the native tricuspid valve through a transcatheter approach

Locations

Country	Name	City	State
Japan	Tokai University Hospital	Isehara-shi	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu-shi	Fukuoka
Japan	Osaka Police Hospital	Osaka-shi	Osaka
Japan	Sendai Kousei Hospital	Sendai-shi	Miyagi
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	Osaka University Hospital	Suita	Osaka
Japan	National Cerebral and Cardiovascular Center	Suita-shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Mortality	Participants with all-cause mortality at 1 year from the index procedure	1 year
Primary	Heart Failure Hospitalization	Participants with a heart failure hospitalization at 1 year from the index procedure	1 year
Secondary	Rates of various adverse events	Rates of various adverse events as defined in the protocol	30 days, 6 months, 12 months, annual for five years
Secondary	Rate of Major Adverse Events (MAEs)	Composite rate of MAEs as defined in the protocol	30 days
Secondary	Reduction in TR grade	Number of participants with reduction in TR from baseline	30 days, 6 months, 12 months, annual for five years
Secondary	New York Heart Association (NYHA) Functional Class	Number of participants with improvement in NYHA class	30 days, 6 months, 12 months, annual for five years
Secondary	Health Status as measured by the SF-36 Questionnaire	Number of points of improvement in health status as measured by 36-item short form survey (SF-36)	30 days, 6 months, 12 months, annual for five years
Secondary	Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Number of points of improvement in health status as measured by KCCQ	30 days, 6 months, 12 months, annual for five years
Secondary	Health Status as measured by the EQ-5D-5L Questionnaire	Number of points of improvement in health status as measured by EQ-5D-5L Questionnaire	30 days, 6 months, 12 months, annual for five years
Secondary	Six-minute walk test	Change in distance (m) from baseline	30 days, 6 months, 12 months, annual for five years