What is the purpose of this trial?
Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.
Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Ages: 18 years and older
Start Date: 03/05/2018
End Date: 10/31/2021
Last Updated: 01/17/2019
Study HIC#: 2000021883