RecruitingNot ApplicableNCT04820764
EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Sponsor
CardioMech AS
Enrollment
25 participants
Start Date
Jul 27, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Eighteen (18) years of age or greater
- Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
- Intermediate or high surgical risk for mitral valve repair
Exclusion Criteria5
- History of rheumatic heart disease
- History of prior endocarditis
- History of prior repair or replacement of the mitral valve, or annuloplasty
- Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
- Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
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Interventions
DEVICECardioMech MVRS
CardioMech MVRS
Locations(12)
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NCT04820764
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