Abbott Medical Devices
The objective of this clinical trial is to evaluate the safety and effectiveness of the Cephea Mitral Valve System in subjects with symptomatic mitral valve disease (MVD) or are deemed unsuitable for surgery and transcatheter repair.
This is a global, prospective interventional multi-center study.
Inclusion Criteria: 1. Mitral valve dysfunction meeting one of the following severity criteria: a. Mitral Annular Calcification (MAC) associated with at least one of the following: i. Grade III or higher mitral regurgitation (MR) ii. Severe mitral stenosis (MS) iii. Concomitant moderate (Grade II) MR and moderate MS b. Grade III or higher MR of primary or secondary etiology 2. The subject is deemed unsuitable for both conventional mitral valve surgery and transcatheter mitral valve repair 3. NYHA functional class II or higher 4. Left Ventricular Ejection Fraction of at least 25% 5. Left V…
During the transcatheter mitral valve replacement procedure, the Cephea Mitral Valve will be placed via transseptal approach
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