MitraClip China Trial

Inclusion Criteria:

1. Age 18 years or older

2. Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic DMR or FMR determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE).

3. Left Ventricular Ejection Fraction (LVEF) is ≥ 20％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).

4. NYHA classification is class II, class III, or ambulatory class IV

5. Subject is deemed difficult for mitral valve surgery due to either STS surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:

1. Porcelain aorta or mobile ascending aortic atheroma

2. Post-radiation mediastinum

3. Previous mediastinitis

4. Functional MR with LVEF < 40%

5. Over 75 years old with LVEF < 40%

6. Re-operation with patent grafts

7. Two or more prior cardiothoracic surgeries

8. Hepatic cirrhosis

9. Other surgical risk factor(s)

6. Mitral valve area ≥ 4.0 cm2 assessed by ECL based transthoracic echocardiogram (TTE) within 90 days prior to subject registration. The ECL may request a transesophageal echocardiogram (TEE).

7. Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration.

8. The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the MitraClip implanting investigator can successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.

9. Transseptal catheterization and femoral vein access is determined to be feasible by the treating physician

10. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethic Committee (EC) of the respective clinical site.

Exclusion Criteria:

1. Leaflet anatomy which may preclude MitraClip implantation, proper positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:

1. Insufficient mobile leaflet available for grasping with the MitraClip device

2. Lack of both primary and secondary chordal support in the grasping area

3. Evidence of significant calcification in the grasping area

4. Presence of a significant cleft in the grasping area

2. Life expectancy < 1 year due to associated non-cardiac comorbid conditions

3. Need for emergent or urgent surgery for any reason

4. Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.

5. Echocardiographic evidence of intracardiac mass, thrombus or vegetation

6. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated)

7. Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration

8. Cerebrovascular accident within 180 days prior to registration

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

10. Any cardiac surgery within 180 days prior to registration

11. Percutaneous coronary intervention (PCI) within the last 30 days prior to registration

12. Implant of Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with Cardioverter Defibrillator (CRT-D) pacemaker or Implantable Cardioverter Defibrillator (ICD) within the last 30 days prior to registration

13. Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration

14. Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment

15. In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT)

16. Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump.

17. History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.

18. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll at least 14 days after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 21 days prior to treatment.

19. Intravenous drug abuse or suspected inability to adhere to follow-up.

20. Patients in whom transesophageal echocardiography (TEE) is contraindicated.

21. A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.

22. In the judgment of the Investigator, subjects in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.

23. Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the MitraClip procedure

24. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials)

25. In the opinion of the investigator or designee, subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.

26. In the opinion of the anesthesiologist, general anesthesia is contraindicated

27. Pregnant or planning pregnancy within next 1 year