Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Eligibility Criteria

• 1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
• 2. Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure.
• 3. Age ≥ 18 years old at the time of enrollment.
• 4. New York Heart Associate Classification ≥ II.
• 5. Symptoms of right heart failure despite optimized medical therapy.
• 6. Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment.
• 7. Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
• 8. The subject has suitable anatomy for investigational device implantation as per imaging requirements.
• 9. The subject has read and signed the informed consent prior to study related procedures.
• 10. The subject is willing and able to comply with all required follow-up evaluations and assessments.
• 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.