Status:

ACTIVE_NOT_RECRUITING

Edwards EVOQUE Eos MISCEND Study

Lead Sponsor:

Edwards Lifesciences

Conditions:

Mitral Valve Regurgitation (Degenerative or Functional)

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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.

Eligibility Criteria

Inclusion

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria

Exclusion

  • Unsuitable anatomy
  • Patient is inoperable

Key Trial Info

Start Date :

February 6 2015

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2033

Estimated Enrollment :

123 Patients enrolled

Trial Details

Trial ID

NCT02718001

Start Date

February 6 2015

End Date

April 30 2033

Last Update

November 27 2024

Active Locations (19)

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Page 1 of 5 (19 locations)

1

Sutter Mills-Peninsula

Burlingame, California, United States, 94010

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

3

Kaiser Permanente San Francisco

San Francisco, California, United States, 94118

4

Emory University Hospital/Emory University Hospital Midtown

Atlanta, Georgia, United States, 30322