Tricuspid Regurgitation
Conditions
Keywords
Functional, TR, FTR, Transcatheter, Repair
Brief summary
Clinical Study of the Edwards Cardioband FIT Repair System
Detailed description
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
Interventions
Repair of the tricuspid valve through a transcatheter approach
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate | 30 days | Number and percentage of patients who experienced at least one major adverse event (MAE). |
| Primary Performance Endpoint - Intraprocedural Success | Intraprocedural | Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis. |
| Primary Performance Endpoint - Clinical Success | 30 days and 1 year | Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam Gray, MD
Lankenau Heart
PRINCIPAL_INVESTIGATORFiras Zahr, MD
Oregon Health and Science University
Outcome results
None listed