The first patients have been enrolled in Cardiac Dimensions’ REDUCE FMR clinical trial. REDUCE FMR is a prospective, double-blind, randomised multicentre trial, evaluating the company’s minimally-invasive Carillon mitral contour system.
Involving up to 20 hospitals in Europe and Australia, REDUCE FMR will randomise 120 patients and is designed to establish Carillon as the gold standard treatment for functional mitral regurgitation. All patients enrolled in the study are on an optimised heart failure medication regimen and are then randomised into two groups: one additionally treated with the Carillon device and the second remaining on an optimised regimen of heart failure medications, the present gold standard.
The study design contains some unique elements aimed at optimising recruitment and enrolment, including a 3:1 randomisation ratio allowing for more data to be collected with Carillon and a cross-over registry which allows control patients to receive Carillon treatment at the end of their 12-month follow up. A built-in exercise echocardiographic sub-study will further evaluate Carillon’s ability to reduce mitral regurgitation, improve functional capacity and quality of life as well as induce reverse ventricular remodelling in a symptomatic heart failure patient population both at rest and during exercise.
The REDUCE FMR trial follows three successful multicentre studies featuring the Carillon device—the AMADEUS, TITAN and TITAN II trials. “My experiences with Carillon have been extremely positive. As an investigator in the last two multicentre trials involving the therapy I have seen significant clinical improvement in patients who receive the device,” said Janusz Lipiecki, of Clinique Pôle Santé République in Clermont Ferrand, France. “In this latest landmark trial, we expect to firmly establish the magnitude of benefit that patients receive from Carillon.”
“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,” said Rick Stewart, chief executive officer of Cardiac Dimensions. “This is the first randomised, blinded study in the field of functional mitral regurgitation, making its results of critical importance in understanding the clinical significance of the Carillon device in this underserved patient population.”