Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Exclusion Criteria

• •Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
• •In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
• •MV orifice area \<4.0 cm2
• •If leaflet flail is present:
• •1. Flail Width ≥15 mm, or
• •2. Flail Gap ≥10 mm.
• •If leaflet tethering is present:
• •1\. Vertical coaptation length \<2 mm
• •Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
• •1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
• •2. Presence of a significant cleft of A2 or P2 scallops
• •3. More than one anatomic criteria dimensionally near the exclusion limits
• •4. Bileaflet flail or severe bileaflet prolapse
• •5. Lack of both primary and secondary chordal support
• •Hemodynamic instability (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
• •Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)
• •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• •Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)
• •History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions
• •Life expectancy \<12 months
• •Active infections requiring current antibiotic therapy
• •Patients in whom transesophageal echocardiography (TEE) is contraindicated
• •High Risk Arm:
• •EF \<20%, and/or LVESD \>60 mm
• •Non-High Risk Arm:
• •The need for any other cardiac surgery
• •Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure
• •Severe Left Ventricular (LV) dysfunction (EF \<25% and/or LVESD \>55mm)
• •Severe mitral annular calcification
• •Systolic anterior motion of the MV leaflet
• •Hypertrophic cardiomyopathy
• •History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months
• •Upper GI bleeding within the prior 6 months
• •Platelet count \<75,000 cells/mm³
• •Creatinine \>2.5mg/dL