A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation

Inclusion Criteria: * Subject is 18 years of age or older * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed * Subject has moderate to severe (3+) or severe (4+) functional mitral regurgitation confirmed by echocardiography core lab * Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated * The local site heart team concurs that mitral valve surgery will not be offered as a first-line treatment option * Subject is a candidate for annuloplasty based on the criteria below as assessed by the investigative site (and confirmed by the Case Review Committee \[CRC\]): Left Ventricular Ejection Fraction (LVEF) ≥ 25% Left Ventricular End Diastolic Diameter (LVEDD) ≤ 65 mm Coaptation distance (i.e. tenting height) \< 10 mm Absence of posterior wall aneurysm Exclusion Criteria: * Subject has severe calcification of the mitral annulus or leaflets or other anatomic features that make the subject unsuitable for annuloplasty with the Millipede System in the judgment of the treating physician or subject does not have suitable mitral annular diameter (determined by CT) as per the Instructions for Use * Transfemoral venous and transseptal access determined not to be feasible * Subject is on the waiting list for a transplant or has had a prior heart transplant * Subject has had a cerebrovascular …