Clinical Study of Edwards Cardioband FIT Valve Repair System
NCT ID: NCT03382457
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
75 participants
INTERVENTIONAL
2018-07-01
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment with the Edwards Cardioband FIT Repair System
Transcatheter Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
Interventions
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Transcatheter Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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William Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Heart
Firas Zahr, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University Medical Center /New York Presbyterian Hospital
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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References
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Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available.
Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.
Other Identifiers
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2017-19
Identifier Type: -
Identifier Source: org_study_id
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