Clinical Study of Edwards Cardioband FIT Valve Repair System

Key Inclusion 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 Key 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 co…