| Moderate-severe (3+) or severe (4+) chronic MR and |
Acute myocardial infarction in the prior 12 weeks of the intended treatment |
| Symptomatic with >25% left ventricular ejection fraction and left ventricular end-systolic diameter ≤55 mm or |
The need for any other cardiac surgery |
| Asymptomatic with one or more of the following: |
Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior |
| (I) LVEF 25% to 60% |
Ejection fraction b25%, and/or end-systolic dimension >55 mm |
| (II) LVESD ≥40 mm |
MV orifice area <4.0 cm2
|
| (III) New onset of atrial fibrillation |
If leaflet flail is present, width of the flail segment ≥15 mm, or flail gap ≥10 mm |
| (IV) Pulmonary hypertension defined as pulmonary artery systolic pressure >50 mm Hg at rest or >60 mmHg with exercise |
Severe mitral annular calcification |
| Candidate for MV repair or replacement surgery, including cardiopulmonary bypass |
If leaflet tethering is present, coaptation depth >11 mm, or vertical coaptation length is <2 mm |
| The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the MV. If a secondary jet exists, it must be considered clinically insignificant |
Leaflet anatomy that may preclude clip implantation, proper clip positioning on the leaflets, or sufficient reduction in MR. This may include the following: |
| Evidence of calcification in the grasping area of the A2 and/or P2 scallops |
| Presence of a significant cleft of A2 or P2 scallops |
| More than 1 anatomic criteria dimensionally near the exclusion limits |
| Bileaflet flail or severe bileaflet prolapse |
| Lack of both primary and secondary chordal support |
| Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted ventricular assist device |
| Echocardiographic evidence of intracardiac mass, thrombus, or vegetation |
| History of or active endocarditis or rheumatic heart disease |
| History of atrial septal defect or patent foramen ovale associated with clinical symptoms |