Clinical Study of the Edwards Cardioband FIT Repair System

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT 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 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