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Edwards EVOQUE Eos MISCEND Study

Edwards Lifesciences logo

Edwards Lifesciences

Status

Active, not recruiting

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Treatments

Device: Edwards EVOQUE Eos Mitral Valve Replacement System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02718001
2013-05C

Details and patient eligibility

About

Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system

Full 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.

Enrollment

123 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Unsuitable anatomy
  • Patient is inoperable

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

123 participants in 1 patient group

Treatment
Experimental group
Description:
Treatment with the Edwards EVOQUE Eos mitral valve replacement system
Treatment:
Device: Edwards EVOQUE Eos Mitral Valve Replacement System

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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