Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

Conditions: Tricuspid Regurgitation, Tricuspid Insufficiency

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 150

Sponsor: Edwards Lifesciences

Location: Ulm University Ulm Bavaria

Summary

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

Eligibility Criteria

* 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03779490). StuddyBuddy aggregates publicly available trial information.