TRISCEND JAPAN Study (TRISCEND JAPAN)

February 15, 2024 updated by: Edwards Lifesciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan
        • Recruiting
        • Kokura Memorial Hospital
        • Principal Investigator:
          • Kenji Ando, MD
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan
        • Recruiting
        • Tokai University Hospital
        • Principal Investigator:
          • Yohei Ohno, MD
    • Miyagi
      • Sendai-shi, Miyagi, Japan
        • Recruiting
        • Sendai Kousei Hospital
        • Principal Investigator:
          • Norio Tada, MD
    • Osaka
      • Osaka-shi, Osaka, Japan
        • Recruiting
        • Osaka Police Hospital
        • Principal Investigator:
          • Yasuhiro Ichibori, MD
      • Suita, Osaka, Japan
        • Recruiting
        • Osaka University Hospital
        • Principal Investigator:
          • Yasushi Sakata, MD
      • Suita-shi, Osaka, Japan
        • Recruiting
        • National Cerebral and Cardiovascular Center
        • Principal Investigator:
          • Kensuke Takagi, MD
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan
        • Recruiting
        • Keio University Hospital
        • Principal Investigator:
          • Kentaro Hayashida, MD
      • Shinjuku-Ku, Tokyo, Japan
        • Recruiting
        • Tokyo Women's Medical University Hospital
        • Principal Investigator:
          • Hiroshi Niinami, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 1 year
Participants with all-cause mortality at 1 year from the index procedure
1 year
Heart Failure Hospitalization
Time Frame: 1 year
Participants with a heart failure hospitalization at 1 year from the index procedure
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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