Cardiac Dimensions has completed primary enrollment of patients for its Reduce FMR clinical trial in Europe and Australia.
The multi-center trial will evaluate Carillon Mitral Contour System to establish it as the gold standard to treat functional mitral regurgitation (FMR), which is a condition in which blood flow to the body is reduced due to an abnormally enlarged mitral valve.
As part of the trial, around 120 patients will be randomized into two groups, of which one will additionally treated with the Carillon device and the second remaining on an optimized regimen of heart failure medications, the present gold standard.
A built-in exercise echocardiographic sub-study will further evaluate the Carillon device’s ability to reduce mitral regurgitation, improve functional capacity and quality of life as well as induce reverse ventricular remodeling in a symptomatic heart failure patient population both at rest and during exercise.
Cardiac Dimensions CEO Rick Stewart said: "The outcomes from REDUCE FMR will be added to the positive data already collected from nearly 100 treated patients evaluated during the three previous prospective trials.
"This is the first randomized, blinded study in the field of FMR, making its results of critical importance in understanding the clinical significance of the CARILLON device in this underserved patient population."
Image: The Carillon Mitral Contour System. Photo: courtesy of Business Wire.