MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Inclusion Criteria: * Subject has given signed study Informed Consent for participation prior to procedure. * Subject is ≥ 18 years of age or legal age in host country * Subject is willing and able to comply with all required follow-up evaluations * Genders eligible for the study: Both genders * Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation; o Subjects with moderate TR: Only NYHA Class III or IV maybe considered for inclusion. * Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion Subject has left ventricular ejection fraction (LVEF) \>20 % * Subject is of functional class 2 or more (NYHA) * The subject is high risk to undergo TV surgery as assessed and consented by a cardiac surgeon and an interventional cardiologist at the site (center heart team), and according to ESC/EACTS guidelines on the management of valvular heart disease. * Patients with Jugular and/or Femoral veins enabling catheterization with 12Fr catheters * Life expectancy ≥ 1 year Exclusion Criteria: * Tricuspid Stenosis \>mild * Tricuspid Subvalvular calcification or calcification of the chordae. * Subjects with Aortic and/or Mitral valve severe stenosis and/or severe regurgitation. * Subjects with severe, uncontrolled hypertension. * Subjects with previous tricuspid repair or replacement. * Subjects, which need to undergo an emergency surgery. * Subjects participating in another clinical investigation. * Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 90 days. * Subject has a history of a myocardial infarction (MI) in the past 90 days. * Subject has had a percutaneous interventional, including coronary intervention (PCI), within the last 90 days before procedure. * Subject has a history of, or has active endocarditis * Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits * Subject is in acute pulmonary edema. * Subject has hemodynamic instability requiring inotropic or mechanical support. * Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication. * Subject has renal insufficiency as evidenced by a serum Creatinine \> 3.0mg/dL. * Subject has ongoing infection or sepsis * Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy) * Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months prior to the index procedure * Subject requires emergency surgery for any reason * 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. * Subject has a known contrast media allergy * Presence of high degree atrio-ventricular block (2nd or 3rd degree A-V block), or the presence of tri-fascicular block * 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) and has a life expectancy of less than 1 year. * Contraindication for treatment with dual antiplatelet therapy for at least 3 months * Contraindication for TEE including trans-gastric views.