MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study

This is an interventional treatment trial for Tricuspid Valve Regurgitation Read More

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.