Transcatheter Tricuspid Valve Reconstruction for Tricuspid Regurgitation
What You Need to Know Before You Apply
What is the purpose of this trial?
Clinical Study of the Edwards Cardioband FIT Repair System
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a hypersensitivity or contraindication to antiplatelets, anticoagulants, or other specified materials, you may not be eligible to participate.
Is the Cardioband Tricuspid Valve Reconstruction System safe for humans?
The Cardioband Tricuspid Valve Reconstruction System has been associated with some safety concerns, such as temporary deformation or blockage of the right coronary artery (a major heart artery) and issues with the device's adjustment mechanism. These complications have been managed successfully in reported cases, but they highlight potential risks that should be considered.12345
How is the Edwards Cardioband Tricuspid Valve Reconstruction System treatment different from other treatments for tricuspid regurgitation?
The Edwards Cardioband Tricuspid Valve Reconstruction System is unique because it is a transcatheter treatment, meaning it is delivered through a catheter (a thin tube) rather than open-heart surgery, which makes it less invasive compared to traditional surgical options for tricuspid regurgitation.678910
What data supports the effectiveness of the treatment Edwards Cardioband Tricuspid Valve Reconstruction System for tricuspid regurgitation?
The Cardioband system, used for tricuspid regurgitation, has shown promising early results in reducing valve leakage and improving patient quality of life, similar to its success in treating mitral regurgitation. However, there are potential complications, such as temporary deformation of nearby arteries, that should be considered.1451112
Who Is on the Research Team?
William Gray, MD
Principal Investigator
Lankenau Heart
Firas Zahr, MD
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
This trial is for adults with chronic functional tricuspid regurgitation (moderate or greater) who still have symptoms despite medical treatment. Candidates should be deemed appropriate for the procedure by a Heart Team but cannot have unsuitable anatomy, primary valve disease, prior repairs or replacements, or conditions that may affect study participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Edwards Cardioband FIT Repair System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Edwards Cardioband Tricuspid Valve Reconstruction System
Edwards Cardioband Tricuspid Valve Reconstruction System is already approved in European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD