Trial of Carillon Mitral Contour System in Cadiac Patients shows positive improvements-Cardiac Dimensions

Cardiac Dimensions announced new long-term outcomes data from the TITAN II clinical trial of its enhanced Carillon Mitral Contour System in Cardiac Surgery patients. This showed significant and sustained improvements in mitral regurgitation, functional improvement, quality of life and reverse cardiac remodeling. A total of 30 patients across five sites were implanted with Carillon devices and were followed for a one-year period as part of the TITAN II trial. Enrolled patients represented a severely ill advanced Heart Failure population at baseline, with an average New York Heart Association classification of III, an average left ventricular ejection fraction of 33 percent and an average mitral regurgitation grade of just under 3+.

Key findings from the study included: significant reductions in functional mitral regurgitation (FMR) as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.3 +/-13.8 ml to 20.6 +/-12.4 ml at 12 months. In addition, eighty percent of patients experienced at least a one class improvement in NYHA classification from baseline to 12 months. There were marked improvement in functional capacity with six-minute walk distances increasing from 294.1+/-82.6 to 381.6+/-130.3 meters at 12 months. Finally, it showed a low 30-day major adverse event rate of 2.8 percent. The data was presented at the 26th annual Transcatheter Cardiovascular Therapeutics Conference.