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Clinical Trials in Japan / NCT05760989
Active, not recruiting Not applicable

TRISCEND JAPAN Study

NCT05760989 · tracked via the Priya Life Science Japan tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2023-02-06
Last updated
2024-08-28

Condition(s) studied

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • All-Cause Mortality — 1 year
    Participants with all-cause mortality at 1 year from the index procedure
  • Heart Failure Hospitalization — 1 year
    Participants with a heart failure hospitalization at 1 year from the index procedure

Trial sites (8)

FacilityCityRegionStatus
Kokura Memorial Hospital Kitakyushu-shi Fukuoka
Tokai University Hospital Isehara-shi Kanagawa
Sendai Kousei Hospital Sendai Miyagi
Osaka Keisatsu Hospital Osaka Osaka
Osaka University Hospital Suita Osaka
National Cerebral and Cardiovascular Center Suita-shi Osaka
Keio University Hospital Shinjuku-Ku Tokyo
Tokyo Women's Medical University Hospital Shinjuku-Ku Tokyo

More Edwards Lifesciences trials in Japan

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Active, not recruiting
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR Recruiting

Other trials for the same condition

Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study) Enrolling by invitation
Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients Active, not recruiting
A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO) Active, not recruiting
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting
Guideline Oriented Approach To Lipid Lowering In Asia-Pacific Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05760989 on ClinicalTrials.gov ↗ ← All trials in Japan