TRISCEND JAPAN Study

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05760989
• Collaborator: (none)
• Enrollment: 45
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 79.8
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases	Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 6, 2023
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Sep 30, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System	Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System; Replacement of the native tricuspid valve through a transcatheter approach

Outcome Measures

Primary Outcome Measures

1. All-Cause Mortality [1 year]

   Participants with all-cause mortality at 1 year from the index procedure

2. Heart Failure Hospitalization [1 year]

   Participants with a heart failure hospitalization at 1 year from the index procedure

Secondary Outcome Measures

1. 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

2. Rate of Major Adverse Events (MAEs) [30 days]

   Composite rate of MAEs as defined in the protocol

3. Reduction in TR grade [30 days, 6 months, 12 months, annual for five years]

   Number of participants with reduction in TR from baseline

4. 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

5. 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)

6. 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

7. 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

8. Six-minute walk test [30 days, 6 months, 12 months, annual for five years]

   Change in distance (m) from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kokura Memorial Hospital	Kitakyushu-shi	Fukuoka	Japan
2	Tokai University Hospital	Isehara-shi	Kanagawa	Japan
3	Sendai Kousei Hospital	Sendai-shi	Miyagi	Japan
4	National Cerebral and Cardiovascular Center	Suita-shi	Osaka	Japan
5	Osaka University Hospital	Suita	Osaka	Japan
6	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan
7	Tokyo Woman's Medical University Hospital	Shinjuku-Ku	Tokyo	Japan

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Study Chair: Yoshihiro Morino, MD, Iwate Medical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT05760989
• Other Study ID Numbers: 2021-21
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Edwards Lifesciences: Transcatheter; Tricuspid Disease; Valve Replacement; Tricuspid Valve
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Mar 9, 2023