Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation
Conditions
Keywords
Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve
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.
Interventions
DEVICEEdwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Replacement of the native tricuspid valve through a transcatheter approach
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in TR grade | 30 days, 6 months, 12 months, annual for five years | Number of participants with reduction in TR from baseline |
| New York Heart Association (NYHA) Functional Class | 30 days, 6 months, 12 months, annual for five years | Number of participants with improvement in NYHA class |
| Health Status as measured by the SF-36 Questionnaire | 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) |
| Rates of various adverse events | 30 days, 6 months, 12 months, annual for five years | Rates of various adverse events as defined in the protocol |
| Health Status as measured by the EQ-5D-5L Questionnaire | 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 |
| Six-minute walk test | 30 days, 6 months, 12 months, annual for five years | Change in distance (m) from baseline |
| Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 30 days, 6 months, 12 months, annual for five years | Number of points of improvement in health status as measured by KCCQ |
| Rate of Major Adverse Events (MAEs) | 30 days | Composite rate of MAEs as defined in the protocol |
Countries
Japan
Outcome results
None listed