Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Age ≥ 18 years
Moderate-severe or severe mitral regurgitation (≥ 3+)
Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
Any stroke/TIA within 30 days
Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
Active infections requiring antibiotic therapy
Active ulcer or gastro-intestinal bleeding in the past 3 months
Single group
CLARITY
DeviceTrans-septal mitral valve replacement
Rate of subjects meeting Technical Success
* Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE
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