Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

• In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:

‣ Optimized medical therapy for treatment of TR (e.g. diuretics).

⁃ Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.

⁃ The Eligibility Committee will confirm that the subject has been adequately treated medically.

• Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).

• The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.

• New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV

• In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.

• Age ≥18 years at time of consent.

• Subject must provide written informed consent prior to any trial related procedure.