TVMR With the Innovalve System Trial - Early Feasibility Study
Purpose
Study to evaluate the safety and performance of the Innovalve 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 - EF<25%
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
MV replacement with Innovalve MR system |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
More Details
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
Detailed Description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system