Clinical Trial of the Week: Device trial for patients diagnosed with tricuspid valve regurgitation

By Donna Loyle, communications specialist, LIMR

 The Edwards Cardioband™ tricuspid valve reconstruction system is being evaluated in an early feasibility study to treat patients with tricuspid regurgitation (TR). Data collected in this prospective, single-arm, multicenter device trial include safety, effectiveness and performance information on qualified subjects for up to five years.

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.

Eligible patients include the following:

  • 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
  • Must have tricuspid valve anatomy appropriate for device deployment and function

Other inclusion and exclusion criteria apply.

The Main Line Health principal investigator for the Cardioband TRICUSPID EFS study is William A. Gray, MD, and it is approved for Lankenau Medical Center. For more, visit https://www.mainlinehealth.org/research/clinical-trials/cardioband

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