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Overall Recruitment Status: Enrollment on-hold |
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Official Title |
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND) |
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Region |
Sponsors |
California - Northern |
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Acronym |
KP IRB No. |
MISCEND |
1770435 |
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Study Type |
Phase |
Clinical Trial |
n/a |
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Study Population Description |
(Adult, Older Adult) Male and Female with Mitral Valve Regurgitation (Degenerative or Functional) |
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Purpose |
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system. |
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Detailed Description |
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system. |
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Gender |
Age Limit |
Male & Female |
18 years & older |
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- Clinically significant, symptomatic mitral regurgitation
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High risk for open-heart surgery
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Meets anatomical criteria
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Mitral Valve Insufficiency
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