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Cardiac Dimensions® Announces Publication of TITAN Clinical Trial Data in European Journal of Heart Failure
Date:5/21/2012

KIRKLAND, Wash., May 21, 2012 /PRNewswire/ -- Cardiac Dimensions®, Inc. today announced that data from its landmark TITAN clinical trial has been published in the most recent issue of the European Journal of Heart Failure. Titled "Treatment of Functional Mitral Regurgitation by Percutaneous Annuloplasty: Results of the TITAN Trial," the manuscript features two-year follow-up data on patients implanted with the CARILLON® Mitral Contour System® as well as one-year follow-up on a non-implanted concurrent comparison group. The CARILLON system is a novel therapy for treating heart patients suffering from functional mitral regurgitation (FMR) and has CE Mark approval, enabling commercialization in Europe.

TITAN (Transcatheter Implantation of CARILLON Mitral Annuloplasty Device) was a prospective, non-randomized, double-arm study evaluating CARILLON in FMR patients. The trial was designed to build upon the foundational results established in the AMADEUS (CARILLON Mitral Annuloplasty Device European Union Study) feasibility study. Fifty-three patients were enrolled in TITAN with 36 patients implanted with the CARILLON device and 17 serving as a non-implanted comparison group. Enrolled patients represented a severely ill advanced heart failure population at baseline, with an average New York Heart Association classification of 3, an average left ventricular ejection fraction below 30 percent and an average mitral regurgitation grade of 3+ to 4+.

Key findings from the study were as follows:

  • Implanted patients demonstrated significant reductions in FMR as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.5 plus or minus 11.5 ml to 17.4 plus or minus 12.4 ml through 12 months (p<0.001).
  • Implanted patients experienced significant reverse remodeling with left ventricular diastolic and systolic volumes decreasing through 12 months, compared to progressive left v
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  • SOURCE Cardiac Dimensions, Inc.
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