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Active, Not Recruiting

NCT Number: NCT05760989

TRISCEND JAPAN Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kokura Memorial Hospital, Kitakyushu-shi, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System

Device

Replacement of the native tricuspid valve through a transcatheter approach

Primary outcomes

  1. All-Cause Mortality

    Time frame: 1 year

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

  2. Heart Failure Hospitalization

    Time frame: 1 year

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

Secondary outcomes

  1. 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

  2. Rate of Major Adverse Events (MAEs)

    Time frame: 30 days

    Composite rate of MAEs as defined in the protocol

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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

  8. Six-minute walk test

    Time frame: 30 days, 6 months, 12 months, annual for five years

    Change in distance (m) from baseline

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study 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

Acronym: TRISCEND JAPAN

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Mar 9, 2023
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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