Clinical Study of Edwards Cardioband FIT Valve Repair System

Exclusion Criteria

• •Patients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:
• •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
• •Primary tricuspid valve disease
• •Any physical impairment which limits the patient's capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition)
• •Currently participating in another investigational biologic, drug, or device study
• •Any of the following cardiovascular procedures:
• •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
• •Any of the following underlying medical conditions:
• •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
• •Pregnant, breastfeeding, or planning pregnancy within the next 12 months
• •Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator