MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Exclusion Criteria

• •Tricuspid Stenosis \>mild
• •Tricuspid Subvalvular calcification or calcification of the chordae.
• •Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
• •Subject has a history of a myocardial infarction (MI) in the past 3 months
• •Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 7 days of the index 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.