Enrollment on hold
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
NCT No.: NCT02718001
Study Type: Clinical Trial
Phase:
n/a
Region: California - Northern
Acronym: MISCEND
Official Title
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Purpose
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
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.
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
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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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Exclusion Criteria
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Unsuitable anatomy;
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Patient is inoperable;
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Keywords and/or Specific Medical Conditions
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Mitral Valve Insufficiency
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Sponsors
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