The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.
Participant who has provided written informed consent for the investigation.
Age ≥18 years.
Patients diagnosed with FMR.
MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
Life expectancy <1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.