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

Inclusion Criteria:

1. Subject is 18 years of age or older
2. 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
3. Subject has moderate to severe (3+) or severe (4+) functional mitral regurgitation confirmed by echocardiography core lab
4. Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated
5. The local site heart team concurs that mitral valve surgery will not be offered as a first-line treatment option
6. 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:

1. 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
2. Transfemoral venous and transseptal access determined not to be feasible
3. Subject is on the waiting list for a transplant or has had a prior heart transplant
4. Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days prior to study enrollment
5. Subject has had any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to study enrollment
6. Subject has had carotid surgery within 30 days prior to study enrollment
7. Subject has had any open coronary or vascular surgery (other than carotid surgery) within 3 months prior to study enrollment
8. Subject has had a cardiac resynchronization therapy (CRT) device implantation within 3 months prior to study enrollment
9. Subject has untreated clinically significant coronary artery disease requiring revascularization
10. Any planned cardiac surgery within the next 12 months
11. Need for emergent or urgent surgery for any reason
12. Subject has severe aortic valve stenosis and/or aortic valve regurgitation
13. Subject has physical evidence of right-sided congestive heart failure (CHF) with echocardiographic evidence of moderate or severe right ventricular dysfunction and/or severe tricuspid valve regurgitation
14. Subject has the presence of prosthetic heart valve in any position
15. Subject has renal insufficiency (eGFR <20mL/min) and is not on dialysis
16. Subject has a life expectancy less than 12 months
17. Subjects in whom trans-esophageal echocardiography-Doppler assessment is contraindicated or in which mitral regurgitation is not measurable by Transthoracic Echocardiography (TTE)
18. Subject has a prior history of atrial septal defect (ASD) closure or patient foramen ovale (PFO) closure
19. Subject has fixed pulmonary artery systolic pressure > 70 mmHG
20. Subject has known hypersensitivity or contraindication to protocol required procedural or post procedural medication (e.g., anticoagulation therapy) or hypersensitivity to nickel or titanium
21. Subject has known hypersensitivity to contrast that cannot be adequately premedicated
22. Female subject who is breast feeding or is pregnant and planning to become pregnant within the study period
23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure
24. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis
25. Subject has oxygen-dependent chronic obstructive pulmonary disease
26. Subject has documented severe liver disease
27. Subject has Hgb <8 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3
28. Subject has any evidence of intracardiac thrombus