Cardiac Dimensions Enrolls First Patients in Carillon Efficacy Trial
Cardiac Dimensions has enrolled the first patients in its clinical trial evaluating the Carillon mitral contour system for the treatment of functional mitral regurgitation, which occurs when blood flow to the body is reduced because of an enlarged mitral valve.
The multicenter trial will enroll 120 patients already taking heart failure medication across 20 hospitals in the EU and Australia, the Kirkland, Wash., devicemaker said Thursday. This is the company’s third study evaluating the Carillon device’s efficacy.
The study’s primary endpoint is demonstrated reduction in regurgitant volume while secondary endpoints include a reduction in major adverse event rates at 30 days and 12 months, a reduction in heart failure hospitalization, a reduction in left ventricle volumes, patient ability to walk distances for six minutes, and increased patient quality of life.
The Carillon system is CE Mark certified, but is not FDA cleared. — Jason Scott