Edwards EVOQUE TMVR Early Feasibility Study
Purpose
Early feasibility study to evaluate the safety and function of the Edwards EVOQUE transcatheter mitral valve replacement system
Condition
- Mitral Valve Regurgitation (Degenerative or Functional)
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
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Treatment |
Treatment with the Edwards EVOQUE transcatheter mitral valve replacement system |
|
Recruiting Locations
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- NCT ID
- NCT02718001
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
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.