• Severe or greater tricuspid valve regurgitation of primary or secondary etiology.

• NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.

• Subject is adequately treated with medical therapy for heart failure \>30 days prior to index procedure, including a diuretic.

• Heart Team determines patient is a recommended candidate for the VDyne System.

• Age 18 years or older at time of the index procedure.

• Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.