Table 1.

Major inclusion and exclusion criteria

Inclusion criteria

Age 18 years or older

Moderate to severe (3+) or severe (4+) chronic mitral valve regurgitation with symptoms or without symptoms but LVEF < 60% or left ventricle end systolic diameter > 45 mm

High-risk candidates for mitral valve surgery including cardiopulmonary bypass

Primary regurgitant jet originating from malcoaptation of the A2 and P2 scallops of the mitral valve; if a secondary jet exists, it must be considered clinically insignificant

Presence of sufficient leaflet tissue for a mechanical coaptation

Non-rheumatic/endocarditic valve morphology

Transseptal catheterization determined to be feasible by the treating physician

Exclusion criteria

Evidence of an acute myocardial infarction in the 12 weeks prior to the intended treatment

Need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic, or tricuspid valve disease

Mitral valve orifice area <4.0 cm2

If leaflet flail is presenta:

flail width ≥15 mmb

flail gap ≥10 mmc

If leaflet tethering is present:

coaptation depth ≥11 mmd

coaptation length <2 mme

Severe mitral annular calcification

Any leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets, or sufficient reduction in MR

Haemodynamic instability defined as systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump

Need for emergency surgery for any reason

Systolic anterior motion of the mitral valve leaflet

Hypertrophic cardiomyopathy

Echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation

History of, or active, endocarditis

History of, or active, rheumatic heart disease

History of atrial septal defect, whether repaired or not

History of patent foramen ovale associated with clinical symptoms (e.g. cerebral ischaemia) or previously repaired or when, in the judgement of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing

History of a stroke or documented TIA within the prior 6 months

Patients in whom TOE is contraindicated

LVEF, left ventricular ejection fraction; TIA, transient ischaemic attack; TOE, transoesophageal echocardiography.

^aFlail is defined as when a leaflet has both ruptured chordae and a free edge that extends above the opposing leaflet or above the plane of the annulus during systole.

^bFlail width is defined as the width of flail leaflet segment as measured along the line of coaptation in the short-axis view.

^cFlail gap is defined as the greatest distance between the ventricular side of the flail leaflet segment to the atrial side of the opposing leaflet edge.

^dCoaptation depth is defined as the shortest distance between the coaptation of the leaflets and the annular plane.

^eCoaptation length is defined as the vertical length of leaflets that is in contact, or is available for contact, during mid-systole in the atrial-to-ventricular direction in the four-chamber view.