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Edwards EVOQUE Eos MISCEND Study
Overall Recruitment Status: Enrollment on-hold
 
Official Title
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
 
Region Sponsors
California - Northern
Edwards Lifesciences
 
Acronym KP IRB No.
MISCEND 1770435
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
(Adult, Older Adult) Male and Female with Mitral Valve Regurgitation (Degenerative or Functional)
 
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.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria
 
Exclusion Criteria
  • Unsuitable anatomy
  • Patient is inoperable

 
Keywords and/or Specific Medical Conditions
  • 2013-05C
  • TMVI
  • Cardiovascular Diseases
  • TMVR
  • Heart Diseases
  • Trans-Septal
  • Heart Valve Diseases
  • Cardiology
  • Mitral Valve Insufficiency
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Cardiology


Principal Investigator:
Jacob Mishell, MD
Contact Information:
- Monica X Kim, RN
-Monica.X.Kim@kp.org
-San Francisco Medical Center


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