EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

The patient population includes all patients suffering from mitral valve disease, indicated for a mitral valve repair procedure, either as a stand-alone procedure or concomitant to a coronary artery bypass grafting, an aortic replacement or tricuspid valve repair and/or the treatment of atrial fibrillation, and for which the surgeon considers the implantation of a Profile 3D annuloplasty product most appropriate to reconstruct the regurgitant valve.

Inclusion Criteria:

• Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher);
• Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care

Exclusion Criteria:

• Heavily calcified valves
• Valvular retraction with severely reduced mobility
• Active bacterial endocarditis
• Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints;
• Life expectancy of less than one year;
• Pregnant or desire to be pregnant within 12 months of the study treatment;
• Under 18 years or over 85 years of age.