Tricuspid Valve RegurgitationTRISCEND JAPANNCT05760989
TRISCEND JAPAN Study
A study testing Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System in people with Tricuspid Valve Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 8 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- What is being tested?
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 8 sitesJapan
- Study dates
- 6 Feb 2023to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic tricuspid regurgitation (TR) despite medical therapy
- TR graded as severe or greater
- Appropriate for transcatheter tricuspid valve replacement per the local heart team
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Tokai University Hospital
Isehara-shi, Kanagawa
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka
Osaka Keisatsu Hospital
Osaka, Osaka
Sendai Kousei Hospital
Sendai, Miyagi
Keio University Hospital
Shinjuku-Ku, Tokyo
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo
Osaka University Hospital
Suita, Osaka
National Cerebral and Cardiovascular Center
Suita-shi, Osaka
About this study
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
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.
- Being tested
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Keywords
- Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement SystemDevice
Replacement of the native tricuspid valve through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System | Experimental | Not described Receives: Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Participants with all-cause mortality at 1 year from the index procedure
Measured: 1 year
Heart Failure Hospitalization
Participants with a heart failure hospitalization at 1 year from the index procedure
Measured: 1 year
Secondary outcomes (8)
Rates of various adverse events
Rates of various adverse events as defined in the protocol
Measured: 30 days, 6 months, 12 months, annual for five years
Rate of Major Adverse Events (MAEs)
Composite rate of MAEs as defined in the protocol
Measured: 30 days
Reduction in TR grade
Number of participants with reduction in TR from baseline
Measured: 30 days, 6 months, 12 months, annual for five years
New York Heart Association (NYHA) Functional Class
Number of participants with improvement in NYHA class
Measured: 30 days, 6 months, 12 months, annual for five years
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)
Measured: 30 days, 6 months, 12 months, annual for five years
Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Number of points of improvement in health status as measured by KCCQ
Measured: 30 days, 6 months, 12 months, annual for five years
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
Measured: 30 days, 6 months, 12 months, annual for five years
Six-minute walk test
Change in distance (m) from baseline
Measured: 30 days, 6 months, 12 months, annual for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start6 Feb 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshihiro Morino, MD, Study chair, Iwate Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760989
- Sponsor's protocol ID
- 2021-12
- Acronym
- TRISCEND JAPAN
- Status last verified
- Aug 2024
- First submitted
- 27 Feb 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05760989
- Acronym / sponsor ID
- TRISCEND JAPAN / 2021-12
- Keywords
- Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System | Experimental | Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic tricuspid regurgitation (TR) despite medical therapy
- TR graded as severe or greater
- Appropriate for transcatheter tricuspid valve replacement per the local heart team
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement SystemReplacement of the native tricuspid valve through a transcatheter approach | Device | Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System |
Primary outcome
All-Cause Mortality
Time frame: 1 year
Participants with all-cause mortality at 1 year from the index procedure
Heart Failure Hospitalization
Time frame: 1 year
Participants with a heart failure hospitalization at 1 year from the index procedure
8 secondary outcomes
Rates of various adverse events
Time frame: 30 days, 6 months, 12 months, annual for five years
Rate of Major Adverse Events (MAEs)
Time frame: 30 days
Reduction in TR grade
Time frame: 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
Health Status as measured by the SF-36 Questionnaire
Time frame: 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
Health Status as measured by the EQ-5D-5L Questionnaire
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihiro Morino, MD study chair
Iwate Medical University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System in people with Tricuspid Valve Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.