TRiluminate - treatment of tricuspid regurgitation

Brief description of study

The purpose of this research study is to compare the performance of the investigational tricuspid valve repair system plus optimal drug therapy with optimal drug therapy alone. Those with moderate or greater tricuspid regurgitation (TR) and have been determined to have symptoms due to heart failure despite being treated with currently available therapies will be asked to participate. TR occurs when the leaflets of the tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. Participants will be randomly assigned to treatment with either the TriClip device or No TriClip device. The TriClip device is investigational and is not approved for clinical use in the tricuspid valve, but is approved by the Food and Drug Administration for experimental use in this research study.




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