Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
45 participants
INTERVENTIONAL
2023-02-06
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment with the 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
Interventions
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Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Replacement of the native tricuspid valve through a transcatheter approach
Eligibility Criteria
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Inclusion Criteria
* TR graded as severe or greater
* Appropriate for transcatheter tricuspid valve replacement per the local heart team
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Yoshihiro Morino, MD
Role: STUDY_CHAIR
Iwate Medical University Hospital
Locations
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Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Osaka Keisatsu Hospital
Osaka, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Countries
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Other Identifiers
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2021-12
Identifier Type: -
Identifier Source: org_study_id
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