Clinical Study of Edwards Cardioband FIT Valve Repair System

Eligibility Criteria

• * Tricuspid regurgitation (moderate or greater)
• * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
• * The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction
• * Patient is willing and able to comply with all specified study evaluations and provides written informed consent
• * Patients in whom transesophageal echocardiography is contraindicated or cannot be completed.
• * Patients in whom tricuspid valve anatomy is not evaluable by TTE or TEE
• * Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), polyester, or contrast media.
• * Previous tricuspid valve repair or replacement with device in place
• * Presence of trans-tricuspid pacemaker or defibrillator leads where: (a)TR is a result of impingement on the tricuspid valve leaflet as evaluated by echocardiography; or (b) implanted in the RV within the last 90 days
• * Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
• * Carotid surgery within the last 30 days
• * Direct current cardioversion within the last 30 days
• * Leadless RV pacemaker implant within the last 30 days
• * Cardiac surgery within the last 90 days
• * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• * Active endocarditis or infection requiring antibiotic therapy (oral or intravenous)
• * Hemodynamically significant pericardial effusion
• * Significant intra-cardiac mass, thrombus, or vegetation
• * Untreated clinically significant coronary artery disease (CAD) requiring revascularization, evidence of acute coronary syndrome, or recent myocardial infarction (MI)
• * Known history of untreated severe symptomatic carotid stenosis (\>50% by ultrasound) or asymptomatic carotid stenosis (\>70% by ultrasound)
• * Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
• * Known bleeding or clotting disorders or patient refuses blood transfusion
• * Active GI bleeding
• * Recent stroke
• * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months or any planned percutaneous cardiac procedure within the next 90 days
• * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months