SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Prospective, single-arm, multicenter early feasibility study

Inclusion criteria

• 18 years of age or older
• MR ≥ 3+
• NYHA functional class ≥ II
• High risk of cardiovascular surgery
• Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

• Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Significant risk of LVOT obstruction
• Severe right ventricular dysfunction
• LV Ejection Fraction <30%
• Patient is inoperable
• Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
• Need for aortic, tricuspid or pulmonic valve replacement
• Presence of mechanical aortic valve prosthesis
• History of cardiac transplantation
• History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
• Clinically significant untreated coronary artery disease requiring revascularization
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
• Stroke or transient ischemic attack within 90 days of the procedure
• Myocardial infarction within 30 days of the procedure
• Active bacterial endocarditis within 180 days of the procedure
• Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
• Irreversible, severe pulmonary hypertension
• Patients with renal insufficiency or receiving renal replacement therapy
• Liver disease or significantly abnormal liver function test results
• Refusal of blood products
• Female who is pregnant or lactating
• Estimated life expectancy < 12 months
• Participating in another investigational drug or device study