A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation (FMR) Subjects.
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.
• Age ≥ 18 yrs.
• Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy Note 1: Functional MR requires the presence of overall or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.
• Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), and after meeting two of the following conditions:
‣ GDMT dose increase of no greater than 100% or decrease of no greater than 50%.
‣ Coronary revascularization and/or implantation of a cardiac resynchronization therapy device (CRT or CRT-D) or reprogramming of the implanted CRT or CRT-D resulting in an increase in biventricular pacing (from \<92% to ≥92%).
• Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and/or have received stable GDMT, as defined in (Appendix IV: Definition of GDMT), confirmed by the local heart team.
• NYHA functional class II to IVa.
• Left ventricular ejection fraction (LVEF) ≥ 20% and ≤50%.
• Left ventricular end-systolic dimension (LVESD) ≤ 70 mm.
• Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the DragonflyTM device.
• Elevated BNP \>150 pg/ml or corrected NT-proBNP ≥600 pg/ml or heart failure hospitalization within the past 12 months ('corrected' refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).
• Transseptal catheterization and femoral vein access is determined to be feasible.
⁃ The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.