A press release to Biospace highlights that Cardiac Dimensions, Inc. a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the company has randomized its first patient in the CARILLON Pivotal Trial.
The CARILLON Trial is evaluating the Carillon® Mitral Contour System® for the treatment of functional mitral regurgitation (FMR) associated with heart failure (HF) as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines. The multi-center, double-blinded, randomized controlled trial is expected to randomize 450 patients at up to 75 centers in North America and Europe. The trial has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status. The CARILLON Trial also includes a cross-over feature that allows patients originally randomized to the control group to receive the Carillon System after their one year follow-up visit.