Status:
ACTIVE_NOT_RECRUITING
Clinical Study of Edwards Cardioband FIT Valve Repair System
Lead Sponsor:
Edwards Lifesciences
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03382457
Start Date
July 1 2018
End Date
December 31 2031
Last Update
October 9 2025
Active Locations (9)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Morristown Medical Center
Morristown, New Jersey, United States, 07962
4
Columbia University Medical Center /New York Presbyterian Hospital
New York, New York, United States, 10032