Study detail
RecruitingObservational
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Edwards Lifesciences
Summary
Study to evaluate the safety and performance of the INNOVALVE system
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 system
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
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%
Interventions
- DeviceINNOVALVE system
INNOVALVE system
Locations (17)
- Cedars-SinaiLos Angeles, California
- Naples Comprehensive HealthNaples, Florida
- Piedmont Heart InstituteAtlanta, Georgia
- NorthwesternChicago, Illinois
- University of Michigan Hospital and Health SystemsAnn Arbor, Michigan
- Mayo ClinicRochester, Minnesota