Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study

Inclusion Criteria: * Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements * Subject is ≥ 18 years of age or legal age in host country * Minimum of moderate functional or degenerative tricuspid regurgitation: * Subjects with moderate TR: Only NYHA (New York Heart Association) Class III or IV maybe considered for inclusion. * Subjects with severe or greater TR: NYHA (New York Heart Association) Class II, III, or IV may be considered for inclusion * Subject has left ventricular ejection fraction (LVEF) \>20 % * The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team). * Femoral or Jugular access of the Steerable Catheter with MDS (Mistral Delivery System) is determined to be feasible. * Subject must agree not to start participating in any other clinical trial for a period of 6 months following the index procedure. * As determined by the center heart team, the Mistral is the suitable treatment option. Exclusion Criteria: * Tricuspid Stenosis \>mild * Tricuspid Sub valvular calcification or calcification of the chordae. * Subjects with Mitral valve severe stenosis and/or severe regurgitation. * Previous tricuspid valve repair or replacement that would interfere with placement of Mistral * Subjects with severe, uncontrolled hypertension. * Subjects, which need to undergo an emergency surgery. * Subject is currently participating in another clinical trial that has not yet completed its primary endpoints. * Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 30 days. * Subject has a history of a myocardial infarction (MI) in the past 30 days. * Subject has had a percutaneous coronary intervention (PCI), within the last 30 days before procedure. * Subject with active endocarditis. * Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits. * Subject has hemodynamic instability requiring inotropic or mechanical support. * Subject has a known hypersensitivity or contraindication to anticoagulant and antiplatelet medication. * Subject is on chronic dialysis. * Bleeding disorders or hypercoagulable state. * In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study. * Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding. * Subject has a known allergy to Nitinol alloys, 316L\\304 stainless steel. * Pregnant or lactating women. * Patients being dependent upon the sponsor or upon the investigator or upon the investigational site. * According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure). * Contraindication for TEE (transesophageal echocardiography) including trans-gastric views. * Life expectancy of less than 1 year