Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, Georgia
RECRUITINGVilnius University Hospital, Santaros Klinikos, Public Institution
Vilnius, Lithuania, Lithuania
RECRUITINGTechnical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).
Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met: 1. The patient is alive. 2. There was successful access, delivery, and retrieval of the device delivery system. 3. The first intended device was successfully deployed and correctly positioned. 4. There was freedom from emergency surgery or reintervention related to the device or access procedure.
Time frame: Periprocedural
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