FDA grant Cardiac Dimensions investigational device exemption approval to conduct study

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CarillonCardiac Dimensions has received FDA approval for its investigational device exemption (IDE) CARILLON trial. The multicentre, blinded, randomised controlled trial is designed to evaluate the Carillon mitral contour system compared with guideline-directed medical management for the treatment of symptomatic functional mitral regurgitation associated with heart failure.

The trial is designed to enrol 400 patients at up to 50 centres in North America, Europe and Australia. The trial has primary safety and efficacy endpoints at 12 months and will follow patients to document long-term safety.

A press release reports that the Carillon system has been studied in three multicentre, prospective clinical trials conducted in Europe and in all studies successfully achieved endpoints of low event rates and reduction of regurgitant volume. Another clinical trial, REDUCE FMR, is currently recruiting participants and is designed to enrol 120 patients at approximately 25 centres in Europe, Australia and New Zealand.

Chairman of the CARILLON trial clinical steering committee, Martin B Leon (Columbia University Medical Center, New York, USA) comments: “This CARILLON trial is an important next step to potentially advance the treatment of patients with functional mitral regurgitation. There is a significant need for a new minimally invasive solution for this extremely ill and under-served patient population, as current mainstream therapies are limited.”