Study ID: Cardioband TRICUSPID EFS
The Edwards Cardioband™ tricuspid valve reconstruction system is being evaluated in an early feasibility study. Data collected in this device trial will include safety, effectiveness and performance data on qualified subjects for up to five years. Patients with tricuspid regurgitation, a leaky heart valve, will be considered for participation.
Benefits to this valve reconstruction may be a decrease in tricuspid regurgitation, alleviation of symptoms related to tricuspid insufficiency and/or improved morbidity and mortality. Currently, treatment options include medical therapy, surgical replacement or repair of the tricuspid valve and alternative investigational transcatheter tricuspid valve repair systems.
This is a prospective, single-arm, multi-center early feasibility study to assess the safety and performance of the Cardioband tricuspid system in the treatment of functional tricuspid regurgitation (TR).
Eligible patients must have chronic TR graded as moderate or greater, and must be symptomatic despite medical therapy (patient must be on diuretic therapy).
Patients must have tricuspid valve anatomy that is appropriate for device deployment and function.
Other inclusion and exclusion criteria apply.
- Must have been diagnosed with chronic functional tricuspid regurgitation (deemed moderate or greater)
- Must be symptomatic despite medical therapy including treatment with a diuretic
- Must be younger than 91 years old
- Please note that the local site heart team determines if the patient is appropriate for transcatheter tricuspid reconstruction