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
Cedars-Sinai
Los Angeles, California 90048
Los Angeles, California 90048
Piedmont Heart Institute
Atlanta, Georgia 30309
Atlanta, Georgia 30309
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
NewYork-Presbyterian / Columbia University
New York, New York 10032
New York, New York 10032
OhioHealth Research Institute
Columbus, Ohio 43214
Columbus, Ohio 43214
Oregon Health & Science Universtiy
Portland, Oregon 97239
Portland, Oregon 97239
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Vanderbilt University Medical Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Swedish Medical Center
Seattle, Washington 98122
Seattle, Washington 98122
More Details
- NCT ID
- NCT04919980
- 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