75 Participants Needed

Transcatheter Tricuspid Valve Reconstruction for Tricuspid Regurgitation

Recruiting at 10 trial locations
TC
Overseen ByTMTT Clinical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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 A. Gray, MD | Main Line Health

William Gray, MD

Principal Investigator

Lankenau Heart

Firas Zahr M.D. | Health care provider ...

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

I have a long-term moderate or severe leak in my heart valve.
I have heart issues related to tricuspid regurgitation that aren't improving with current treatment.
My heart team has approved me for a specific heart valve procedure.

Exclusion Criteria

My body's structure makes me ineligible for the procedure.
My heart condition is related to the tricuspid valve.
Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Edwards Cardioband FIT Repair System

2-7 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Multiple visits (in-person) at 30 days and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Edwards Cardioband Tricuspid Valve Reconstruction System
Trial Overview The Edwards Cardioband Tricuspid Valve Reconstruction System is being tested in this clinical study. It's a minimally invasive procedure designed to repair the heart's tricuspid valve without needing open-heart surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

Edwards Cardioband Tricuspid Valve Reconstruction System is already approved in European Union for the following indications:

🇪🇺
Approved in European Union as Edwards Cardioband Tricuspid Valve Reconstruction System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton profile image

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian profile image

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

In a study of 51 patients undergoing Cardioband implantation for tricuspid regurgitation, 14 patients experienced acute deformation of the right coronary artery (RCA) during the procedure.
Follow-up angiographies showed that all cases of RCA deformation resolved completely without any clinical symptoms, suggesting that this complication is reversible and that a watchful waiting approach is safe and effective, avoiding unnecessary interventions.
Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system.Gerçek, M., Rudolph, V., Arnold, M., et al.[2023]
In a study involving 30 patients with severe functional tricuspid regurgitation, the Cardioband tricuspid valve reconstruction system demonstrated a high procedural success rate of 93% and no 30-day mortality, indicating its safety and feasibility for this patient population.
At 30 days post-procedure, 85% of patients experienced at least a one-grade reduction in tricuspid regurgitation, with significant improvements in functional status as evidenced by a 16-point increase in quality of life scores and a shift from more severe heart failure classes to milder ones.
Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.Davidson, CJ., Lim, DS., Smith, RL., et al.[2021]
The Cardioband® tricuspid valve reconstruction system can effectively adjust ring size but poses a risk of causing subtotal occlusion of the right coronary artery (RCA), as demonstrated in a reported patient case.
This complication can be challenging to treat, as traditional methods of re-canalization may fail, necessitating alternative approaches for successful intervention.
Subtotal occlusion of the right coronary artery by Cardioband and its successful intervention via retrograde approach. Interventional flashlight.Habedank, D., Bierschenk, S., Zimpel, S., et al.[2023]

Citations

Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system. [2023]
Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. [2021]
Subtotal occlusion of the right coronary artery by Cardioband and its successful intervention via retrograde approach. Interventional flashlight. [2023]
The Cardioband transcatheter annular reduction system. [2020]
Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. [2020]
Tricuspid valve in valve procedure with an Edwards S3 valve© in a 10 kg child. [2022]
Tangled wire in a Dacron band during Cardioband transcatheter tricuspid annuloplasty-How to solve the problem. [2021]
Recurrent trigeminocardiac reflex in percutaneous balloon compression for trigeminal neuralgia: A case report. [2022]
Case report: 2 cases of cardiac arrest caused by rhino-cardiac reflex while disinfecting nasal cavity before endonasal transsphenoidal endoscopic pituitary surgery. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Management of middle meningeal and superficial temporal artery hemorrhage from total temporomandibular joint replacement surgery with a gelatin-based hemostatic agent. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Intra-Arterial Lidocaine Blunts the Trigeminocardiac Reflex during Endovascular Treatment of a Carotid-Cavernous Fistula. [2021]
Trigeminocardiac reflex during non-surgical root canal treatment of teeth with irreversible pulpitis. [2018]
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