Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Exclusion Criteria

• •1. Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
• •2. Severe RV dysfunction as assessed by echocardiography.
• •3. Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
• •4. Currently participating in another investigational drug or device study.
• •5. Systolic pulmonary arterial pressure (sPAP) \> 70 mmHg as measured by Transthoracic Echocardiography (TTE).
• •6. 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.
• •7. Tricuspid valve stenosis.
• •8. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.
• •9. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
• •10. Prior tricuspid repair or tricuspid replacement.
• •11. Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.
• •12. History of cardiac transplantation.
• •13. Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE).
• •14. Endocarditis or severe infection within 12 months of scheduled implant procedure.
• •15. Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.
• •16. Cerebro-Vascular Accident within the previous 3 months.
• •17. Hemodynamic instability or on IV inotropes.
• •18. Contraindication to anticoagulant therapy and dual antiplatelet therapy.
• •19. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.
• •20. Severe renal impairment or on dialysis.
• •21. Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy \< 1 year), or lead to difficulties for subject compliance with study requirements.
• •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 transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
• •28. Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.
• •29. Contra-indicated for blood transfusion or refuses transfusion.
• •30. Patient undergoing emergency treatment.
• •31. Patient without appropriate jugular access.