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.

Sex

Male & Female

Age Limit

18 years & older

Eligibility Criteria

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
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Valve Diseases
  • Mitral Valve Insufficiency
  • Severe
  • TMVI
  • TMVR
  • Transeptal,
  • Trans-Septal
  • Cardiology

Sponsors

  • Edwards Lifesciences

KP Clinical Facility

Clinical Area

  • Cardiology

Principal Investigator

Jacob Mishell , MD 

Contact Information

 - CTP Collaborate X , RN
- ctpcollaborate@kp.org
- San Francisco Medical Center

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