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TRISCEND JAPAN Study (TRISCEND JAPAN)

Primary Purpose

Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Regurgitation focused on measuring Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kokura Memorial HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Sendai Kousei HospitalRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • Osaka University HospitalRecruiting
  • Keio University HospitalRecruiting
  • Tokyo Women's Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rates of various adverse events
Rates of various adverse events as defined in the protocol
Rate of Major Adverse Events (MAEs)
Composite rate of MAEs as defined in the protocol
Reduction in TR grade
Number of participants with reduction in TR from baseline
New York Heart Association (NYHA) Functional Class
Number of participants with improvement in NYHA class
Health Status as measured by the SF-36 Questionnaire
Number of points of improvement in health status as measured by 36-item short form survey (SF-36)
Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Number of points of improvement in health status as measured by KCCQ
Health Status as measured by the EQ-5D-5L Questionnaire
Number of points of improvement in health status as measured by EQ-5D-5L Questionnaire
Six-minute walk test
Change in distance (m) from baseline

Full Information

First Posted
February 27, 2023
Last Updated
June 27, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT05760989
Brief Title
TRISCEND JAPAN Study
Acronym
TRISCEND JAPAN
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
Keywords
Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Intervention Description
Replacement of the native tricuspid valve through a transcatheter approach
Primary Outcome Measure Information:
Title
All-Cause Mortality
Description
Participants with all-cause mortality at 1 year from the index procedure
Time Frame
1 year
Title
Heart Failure Hospitalization
Description
Participants with a heart failure hospitalization at 1 year from the index procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rates of various adverse events
Description
Rates of various adverse events as defined in the protocol
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Rate of Major Adverse Events (MAEs)
Description
Composite rate of MAEs as defined in the protocol
Time Frame
30 days
Title
Reduction in TR grade
Description
Number of participants with reduction in TR from baseline
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
New York Heart Association (NYHA) Functional Class
Description
Number of participants with improvement in NYHA class
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Health Status as measured by the SF-36 Questionnaire
Description
Number of points of improvement in health status as measured by 36-item short form survey (SF-36)
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Number of points of improvement in health status as measured by KCCQ
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Health Status as measured by the EQ-5D-5L Questionnaire
Description
Number of points of improvement in health status as measured by EQ-5D-5L Questionnaire
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Six-minute walk test
Description
Change in distance (m) from baseline
Time Frame
30 days, 6 months, 12 months, annual for five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Saeki
Phone
03-6894-0500
Email
Aya_Saeki@edwards.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reiko Masui
Email
Reiko_Masui@edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshihiro Morino, MD
Organizational Affiliation
Iwate Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kokura Memorial Hospital
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenji Ando, MD
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohei Ohno, MD
Facility Name
Sendai Kousei Hospital
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norio Tada, MD
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-shi
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kensuke Takagi, MD
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasushi Sakata, MD
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kentaro Hayashida, MD
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Niinami, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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