Mitral Valve Regurgitation Clinical Trials

• Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity

• NYHA II, III, or IV

• Six Minute Walk distance ≥ 100 meters and ≤ 600 meters

• Left Ventricular Ejection Fraction ≤ 50%

• LVEDD:

‣ ≥ 55 mm (women)

⁃ ≥ 57 mm (men)

• LVESD ≤ 75 mm

• Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.

• Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee

• Age ≥ 18 years old

⁃ Carillon implant can be sized and placed in accordance with the IFU

⁃ The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent