The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* Inclusion Criteria:
* Eighteen (18) years of age or older
* Moderate or greater functional Tricuspid Regurgitation (TR)
* Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.
* Exclusion Criteria:
* Patients deemed anatomically unsuitable for the device by echocardiography
* Patients in whom transesophageal echocardiography (TEE) is contraindicated
* Previous tricuspid valve repair or replacement
* Severe aortic, mitral and / or pulmonic valve stenosis
* Severe aortic, mitral and / or pulmonic valve regurgitation
* Renal Insufficiency requiring dialysis or severe kidney renal disease
* Life expectancy of less than twelve months
* Patient is pregnant or lactating
Primary outcome measure(s)
Procedure Success — Hospital discharge, 2-7 days post-procedure Reduction in severity of Tricuspid Regurgitation at discharge.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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