TVMR With the Innovalve System Trial - Early Feasibility Study
- Conditions
- Mitral Valve Regurgitation (Degenerative or Functional)
- Interventions
- Device: Innovalve MR system
- Registration Number
- NCT04919980
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
- Unsuitable anatomy
- Patient is inoperable
- EF<25%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Innovalve MR system MV replacement with Innovalve MR system
- Primary Outcome Measures
Name Time Method Absence of implant or delivery related serious adverse events at 30 days 30 days Absence of implant or delivery related serious adverse events
- Secondary Outcome Measures
Name Time Method Technical success Procedure Procedural success 30 days NYHA functional class 30 days, 3, 6, 12 months and annually up to 5 years Six-minute walk test 30 days, 3, 6, 12 months and annually up to 5 years Quality of life improvement (KCCQ-12) 30 days, 3, 6, 12 months and annually up to 5 years Reduction in MR grade 30 days, 3, 6, 12 months and annually up to 5 years
Trial Locations
- Locations (12)
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
University of Michigan Hospital and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Cornell
🇺🇸New York, New York, United States
Oregon Health & Science Universtiy
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Cedars-Sinai
🇺🇸Los Angeles, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
NewYork-Presbyterian / Columbia University
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States