Clinical trial NCT05760989: TRISCEND JAPAN 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Keywords: Transcatheter
Tricuspid Disease
Valve Replacement
Tricuspid Valve
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2023-03-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All-Cause Mortality
timeFrame: 1 year
measure: Heart Failure Hospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Rates of various adverse events
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: Rate of Major Adverse Events (MAEs)
timeFrame: 30 days
measure: Reduction in TR grade
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: Health Status as measured by the SF-36 Questionnaire
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: Health Status as measured by the EQ-5D-5L Questionnaire
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: Six-minute walk test
timeFrame: 30 days, 6 months, 12 months, annual for five years
Other outcomes:
Locations:
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Osaka Keisatsu Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
Study officials:
affiliation: Iwate Medical University Hospital
name: Yoshihiro Morino, MD
role: STUDY_CHAIR
References: