Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation

Inclusion Criteria:

1. Age ≥ 18 yrs.
2. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic ornon-ischemic cardiomyopathy Note 1: Functional MR requires the presence of overall orlocalized LV wall motion abnormalities that are considered to be the primary cause ofMR. Despite the eligibility, subjects may not enroll if leaflet prolapse or otherevidence of degenerative MR is present. Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 daysafter the subject has been stabilized on optimal therapy with Guideline DirectedMedical Therapy (GDMT), and after meeting two of the following conditions:
3. GDMT dose increase of no greater than 100% or decrease of no greater than 50%.
4. Coronary revascularization and/or implantation of a cardiac resynchronizationtherapy device (CRT or CRT-D) or reprogramming of the implanted CRT or CRT-Dresulting in an increase in biventricular pacing (from <92% to ≥92%).
5. Subjects have been adequately treated according to applicable criteria, includingtreatment for coronary artery disease, left ventricular dysfunction, mitralregurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT orCRT-D), coronary revascularization, and/or have received stable GDMT, as defined in (Appendix IV: Definition of GDMT), confirmed by the local heart team.
6. NYHA functional class II to IVa.
7. Left ventricular ejection fraction (LVEF) ≥ 20% and ≤50%.
8. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm.
9. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge techniqueand can be treated by the DragonflyTM device.
10. Elevated BNP >150 pg/ml or corrected NT-proBNP ≥600 pg/ml or heart failurehospitalization within the past 12 months ('corrected' refers to a 4% reduction in theBNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).
11. Transseptal catheterization and femoral vein access is determined to be feasible.
12. The subject or subject's legal representative has been informed of the nature of thetrial, willing to accept the experimental tests, and has provided written informedconsent.

Exclusion Criteria:

1. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
2. The presence of other severe heart valve disease requiring surgical intervention.
3. Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.
4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis,infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.),or any other structural heart disease causing heart failure other than dilatedcardiomyopathy of either ischemic or non-ischemic etiology.
5. Moderate to severe right heart dysfunction or an estimated pulmonary artery systolicpressure (PASP) > 70 mmHg assessed by echocardiography.
6. History of acute myocardial infarction in the prior 4 weeks or untreated clinicallysignificant coronary artery disease requiring revascularization.
7. Any percutaneous cardiac intervention within the 30 days, or any cardiac surgerywithin the 6 months prior to randomization, or any implant of any CardiacResynchronization Therapy (CRT) or Cardiac Resynchronization Therapy withcardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD)within the last 30days prior to subject registration.
8. In the judgment of the investigator, the subject's femoral vein is unable toaccommodate a 25F catheter or has an ipsilateral deep venous thrombosis; or theanatomy is not accessible for transseptal puncture.
9. Subjects in whom transesophageal echocardiography (TEE) or general anesthesia iscontraindicated.
10. End-stage heart failure (ACC/AHA stage D), or prior orthotopic heart transplantation,or on the waiting list for heart transplantation.
11. Active endocarditis, or active rheumatic heart disease, or leaflets degenerated fromeither endocarditis or rheumatic disease.
12. Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygentherapy or long-term application of steroid hormone medication).
13. Cerebrovascular accident within 30 days prior to randomization or symptomatic severecarotid stenosis (> 70% by ultrasound), or carotid artery stenting within 30 days.
14. Evidence of acute peptic ulcer or gastrointestinal hemorrhage in the prior 3 months.
15. Hemorrhagic or coagulopathic disorders, contraindications to antithromboticmedication.
16. Modified Rankin Scale ≥4.
17. The subjects suffer from diseases that may lead to difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.).
18. Pregnant or breastfeeding women, or women who plan to become pregnant within the next 12 months. Note: Women of childbearing age should take a pregnancy test with anegative result within 14 days prior to registration and use scientifically safecontraception
19. Hemodynamic instability defined as systolic pressure < 90 mmHg without afterloadreduction, cardiogenic shock, or the need for inotropic support or an intra-aorticballoon pump.
20. Active infections requiring antibiotic therapy (in the case of temporary illness,antibiotics must be discontinued for at least 14 days before the subject can beenrolled).
21. Currently participating in an investigational drug or another device study that hasnot completed its primary endpoints or would clinically interfere with the endpoint ofthis study. Note: Trials requiring extended follow-up for products that wereinvestigational, but have since become commercially available, are not consideredinvestigational trials.
22. In the judgment of the investigator, subjects may not complete the trial according topoor compliance or in other circumstances when the investigator determines that thesubject is unfit to participate in the study.