Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Inclusion Criteria

• Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
• 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.
• Age ≥ 18 years old at the time of enrollment.
• New York Heart Associate Classification ≥ II.
• Symptoms of right heart failure despite optimized medical therapy.
• 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.
• Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
• The subject has suitable anatomy for investigational device implantation as per imaging requirements.
• The subject has read and signed the informed consent prior to study related procedures.
• The subject is willing and able to comply with all required follow-up evaluations and assessments.

Exclusion Criteria

• Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
• Severe RV dysfunction as assessed by echocardiography.
• Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
• Currently participating in another investigational drug or device study.
• Systolic pulmonary arterial pressure (sPAP) > 70 mmHg as measured by Transthoracic Echocardiography (TTE).
• 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.
• Tricuspid valve stenosis.
• Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.
• Intra-cardiac thrombus, mass or vegetation requiring active treatment.
• Prior tricuspid repair or tricuspid replacement.
• Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.
• History of cardiac transplantation.
• Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE).
• Endocarditis or severe infection within 12 months of scheduled implant procedure.
• Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.
• Cerebro-Vascular Accident within the previous 3 months.
• Hemodynamic instability or on IV inotropes.
• Contraindication to anticoagulant therapy and dual antiplatelet therapy.
• Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.
• Severe renal impairment or on dialysis.
• 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.
• Acute anemia.
• Chronic Oral Steroid Use ≥ 6 months.
• Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
• Pulmonary embolism within the last 6 months.
• Tricuspid Valve Tethering distance > 10 mm.
• Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
• Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.
• Contra-indicated for blood transfusion or refuses transfusion.
• Patient undergoing emergency treatment.
• Patient without appropriate jugular access.