Edwards EVOQUE Eos MISCEND Study
- Conditions
- Mitral Valve Regurgitation (Degenerative or Functional)
- Interventions
- Device: Edwards EVOQUE Eos Mitral Valve Replacement System
- Registration Number
- NCT02718001
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Detailed Description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
- Unsuitable anatomy
- Patient is inoperable
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Edwards EVOQUE Eos Mitral Valve Replacement System Treatment with the Edwards EVOQUE Eos mitral valve replacement system
- Primary Outcome Measures
Name Time Method Composite of major adverse events 30 days Proportion of patients with major adverse events
- Secondary Outcome Measures
Name Time Method Clinical Success 30 days Proportion of patients with procedural success without major adverse events
Procedural Success Discharge or 7 days post-procedure, whichever occurs first Proportion of patients with device success without significant paravalvular leak
NYHA functional class 30 days, 6 Months, 12 Months, annual for five years Number of patients with improvement in NYHA class
Reduction in MR grade 30 days, 6 Months, 12 Months, annual for five years Number of patients with reduction in MR grade from baseline
Device Success Immediately after procedure Proportion of patients with device deployed as intended and delivery system successfully retrieved
Six minute walk test 30 days, 6 Months, 12 Months, annual for five years Increase in distance (m) from baseline
Trial Locations
- Locations (19)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Sutter Mills-Peninsula
🇺🇸Burlingame, California, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
The Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Emory University Hospital/Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval
🇨🇦Québec, Canada
St. Michael's Hospital
🇨🇦Toronto, Canada
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada