Cardiac Dimensions Begins Enrollment for REDUCE FMR Trial of the Carillon Mitral Contour System

June 25, 2015—Cardiac Dimensions announced the commencement of a clinical trial for its Carillon mitral contour system as a treatment for functional mitral regurgitation (FMR). The first patients have been enrolled in REDUCE FMR, which is a prospective, double-blind, multicenter trial that will randomize 120 patients at up to 20 hospitals in Europe and Australia.

Cardiac Dimensions stated that the Carillon system is a percutaneous mitral annuloplasty treatment option that can be deployed safely and rapidly using standard interventional techniques. The implantable device consists of a distal anchor and a proximal anchor connected by a shaping ribbon and utilizes the heart’s venous anatomy to reshape the mitral annulus.

According to Cardiac Dimensions, all patients enrolled in the study are on an optimized heart failure medication regimen, which is the current gold standard of treatment for FMR. The patients are then randomized into two groups: treatment with the Carillon device in addition to the continued medication regimen versus the continued optimized regimen of heart failure medication alone. 

The trial has several features intended to optimize recruitment and enrollment, including a 3:1 randomization ratio that will allow for more data to be collected with the Carillon device, as well as a cross-over registry that allows control patients to receive Carillon treatment at the end of their 12-month follow-up. There will also be a built-in exercise echocardiographic substudy that will further evaluate the Carillon device’s ability to reduce mitral regurgitation, improve functional capacity and quality of life, and induce reverse ventricular remodeling in a symptomatic heart failure patient population both at rest and during exercise.

The REDUCE FMR clinical trial follows three successful multicenter studies featuring the Carillon device: the AMADEUS, TITAN, and TITAN II trials, noted the company.

In the company’s press release, Janusz Lipiecki, MD, commented, “My experiences with Carillon have been extremely positive. As an investigator in the last two multicenter trials involving the Carillon therapy, I’ve seen significant clinical improvement in patients who receive the device. In this latest landmark trial, we expect to firmly establish the magnitude of benefit that patients receive from Carillon.” Dr. Lipiecki is with Clinique Pôle Santé République in Clermont Ferrand, France.