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Purpose

Early feasibility study to evaluate the safety and function of the Edwards EVOQUE transcatheter mitral valve replacement system

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Unsuitable anatomy
  • Patient is inoperable

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment 		Treatment with the Edwards EVOQUE transcatheter mitral valve replacement system
  • Device: Edwards EVOQUE Transcatheter Mitral Valve Replacement System
    Replacement of the mitral valve through a transcatheter approach
    Other names:
    • CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV)
    • Edwards FORTIS™ Transcatheter Mitral Valve (TMV)
    • Transcatheter Mitral Valve Replacement (TMVR)

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

TMTT Clinical
(949) 250-2500
TMTT_Clinical@edwards.com

Detailed Description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and function of the Edwards EVOQUE transcatheter mitral valve replacement system.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.