Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU

Inclusion Criteria:

1. Participant who has provided written informed consent for the investigation.

2. Age ≥18 years.

3. Patients diagnosed with FMR.

4. MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).

5. LVEF ≥20% to ≤60%.

6. Symptom status: NYHA functional class II to IV despite a stable maximally toleratedGDMT regimen as per guidelines.

7. According to the judgment of local cardiology team, subjects have undergone adequatetreatment for at least 30 days (preferably 90 days) based on the criteriarecommended in the heart failure guidelines.

8. Subject fulfils FMR anatomy selection criteria.

9. According to the judgment of the local Cardiovascular medical-surgery team, subjectswho have high or prohibitive risk for open heart surgery.

10. Left ventricular end-systolic diameter (LVESD)≤70mm.

11. The MR beam mainly originates from the A2/P2 area.

12. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length ofanterior and posterior leaflets>10mm.

13. Mitral valve effective orifice area (EOA) ≥ 4.0cm2.

14. No obvious calcification of main grasp mitral valve leaflets.

15. Patient anatomy allows atrial septum approach.

Exclusion Criteria:

1. Life expectancy <1 year due to non-cardiac conditions or heart failure deemedsuitable for palliative treatment.

2. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support ormechanical hemodynamic support.

3. UNOS status 1 heart transplantation or prior orthotopic heart transplantation.

4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis,or any other structural heart disease causing heart failure other than dilatedcardiomyopathy of either ischemic or non-ischemic etiology.

5. Fixed pulmonary artery systolic pressure >70 mm Hg.

6. Physical evidence of right-sided congestive heart failure with echocardiographicevidence of moderate or severe right ventricular dysfunction.

7. Mitral valve anatomy which may preclude proper device treatment.

8. Mitral valve area < 4.0 cm2 (if new device therapy may further decrease the mitralorifice area).

9. Any prior mitral valve surgery or transcatheter mitral valve procedure.

10. Stroke or transient ischemic event within 30 days before enrolment.

11. Modified Rankin ≥ Scale 4 disability.

12. Severe symptomatic carotid stenosis (>70% by ultrasound).

13. Need for emergent or urgent intervention for any reason or any planned cardiacintervention within the next 12 months.

14. Implant or revision of any rhythm management device (CRT or CRT-D) or implantablecardioverter-defibrillator within 1 month before enrolment.

15. Untreated clinically significant coronary artery disease requiringrevascularization.

16. Any percutaneous cardiovascular intervention, cardiovascular intervention, orcarotid intervention within 30 days

17. Tricuspid valve disease requiring intervention or severe or more tricuspidregurgitation.

18. Aortic valve disease requiring intervention or any concomitant treatment.

19. Need for any cardiovascular intervention (other than for MV disease).

20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

21. Active endocarditis.

22. Active infections requiring current antibiotic therapy.

23. Subjects in whom transoesophageal echocardiography is contraindicated or high risk.

24. Any condition making it unlikely the patient will be able to complete all protocolprocedures (including compliance with guideline directed medical therapy) andfollow-up visits.

25. Patient unable or unwilling to provide written, informed consent before studyenrolment.

26. Pregnant woman or woman planning to become pregnant.

27. Patients with severe liver, renal or pulmonary disease, which in investigatoropinion may have an impact on patient safety.

28. Clinically significant lab abnormalities which in investigator opinion may have animpact on patient safety.