EVEREST II Pivotal Study High Risk Registry (HRR)

Inclusion Criteria

Candidates for the high risk arm of the study must meet all of the following inclusion criteria:

• Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk surgical candidate due to the presence of one of the following indications:
• Porcelain aorta or mobile ascending aortic atheroma
• Post-radiation mediastinum
• Previous mediastinitis
• Functional MR with EF 2.5 mg/dL ii) Prior chest surgery iii) Age over 75 iv) EF 60 mm as defined in Appendix A of the EVEREST II protocol.
• Mitral valve orifice area < 4.0 cm2 as defined in Appendix A of the EVEREST II protocol.
• If leaflet flail is present:
• Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4.3 and Appendix A, or
• Flail Gap: the flail gap is greater than or equal to 10 mm, as defined in Section 4.3 and Appendix A.
• If leaflet tethering is present:

a). Coaptation Length: the vertical coaptation length is less than 2 mm, as defined in Section 4.3 and Appendix A.

• Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
• 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 one anatomic criteria dimensionally near the exclusion limits
• Bileaflet flail or severe bileaflet prolapse
• Lack of both primary and secondary chordal support
• Hemodynamic instability defined as systolic pressure < 90 mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.
• Need for emergent or urgent surgery for any reason.
• Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased (i.e. noncompliant, perforated).
• History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
• Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
• Intravenous drug abuse or suspected inability to adhere to follow-up.
• Patients in whom transesophageal echocardiography (TEE) is contraindicated.
• A known hypersensitivity or contraindication to study or
• In the judgment of the Investigator, patients 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.
• 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].