Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive the trial device.
CRITERIA LIST/ QUALIFICATIONS:
Symptomatic, severe mitral regurgitation
NYHA functional classification ≥ II (If Class IV, patient must be ambulatory)