NCT05760989

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
41mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Feb 2023Sep 2029

Study Start

First participant enrolled

February 6, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Expected
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2.6 years

First QC Date

February 27, 2023

Last Update Submit

August 27, 2024

Conditions

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Keywords

TranscatheterTricuspid DiseaseValve ReplacementTricuspid Valve

Outcome Measures

Primary Outcomes (2)

  • All-Cause Mortality

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

    1 year

  • Heart Failure Hospitalization

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

    1 year

Secondary Outcomes (8)

  • Rates of various adverse events

    30 days, 6 months, 12 months, annual for five years

  • Rate of Major Adverse Events (MAEs)

    30 days

  • Reduction in TR grade

    30 days, 6 months, 12 months, annual for five years

  • New York Heart Association (NYHA) Functional Class

    30 days, 6 months, 12 months, annual for five years

  • Health Status as measured by the SF-36 Questionnaire

    30 days, 6 months, 12 months, annual for five years

  • +3 more secondary outcomes

Study Arms (1)

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

EXPERIMENTAL
Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System

Interventions

Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement SystemDEVICE

Replacement of the native tricuspid valve through a transcatheter approach

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Location

Tokai University Hospital

Isehara-shi, Kanagawa, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Location

Osaka Keisatsu Hospital

Osaka, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

National Cerebral and Cardiovascular Center

Suita-shi, Osaka, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Yoshihiro Morino, MD

    Iwate Medical University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

February 6, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2029

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(8)