Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Exclusion Criteria

• •1. Currently participating in another investigational drug or device study.
• •2. Subject with Systolic pulmonary arterial pressure (sPAP) \> 60mmHg as measured by Transthoracic Echocardiography (TTE)
• •3. Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure
• •4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
• •5. Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
• •6. Mitral stenosis and/or regurgitation more than moderate
• •7. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
• •8. Implanted inferior vena cava (IVC) filter.
• •9. Prior tricuspid repair or tricuspid replacement
• •10. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
• •11. History of cardiac transplantation
• •12. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
• •13. Endocarditis or severe infection within 12 months of scheduled implant procedure
• •14. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
• •15. Cerebro Vascular Accident within the previous 6 months
• •16. Hemodynamic instability or on IV inotropes
• •17. Contraindication to anticoagulant therapy and antiplatelet therapy
• •18. Bleeding disorders or hypercoagulable condition (at risk of blood clots
• •19. Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure
• •20. Severe renal impairment or on dialysis
• •21. Life expectancy less than 12 months.
• •22. Acute anemia
• •23. Chronic Oral Steroid Use ≥ 6 months
• •24. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
• •25. Pulmonary embolism within the last 6 months
• •26. Tricuspid Valve Tethering distance \> 10 mm
• •27. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
• •28. Contra-indicated for blood transfusion or refuses transfusion
• •29. Patient undergoing emergency treatment
• •30. Patient without appropriate venous access