Cardiac Dimensions has announced that new long-term outcomes data from the TITAN II clinical trial of its enhanced Carillon mitral contour system showed significant and sustained improvements in mitral regurgitation, functional improvement, quality of life and reverse cardiac remodelling. The long-term safety and efficacy data, which was consistent with previous trials of the system, was presented at the recent Transcatheter Cardiovascular Therapeutics Conference (TCT) meeting (13–17 September, Washington, USA) by TITAN II investigator Michael Haude (Lukaskrankenhaus in Neuss, Germany).
A press release reports that TITAN II was a prospective, single-arm European multicentre clinical trial initiated to further evaluate an enhanced version of the Carillon system. It adds that the Carillon is designed to treat heart failure patients suffering from functional mitral regurgitation.
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 (NYHA) classification of III, an average left ventricular ejection fraction of 33% and an average mitral regurgitation grade of just under 3+. Key findings from the study included:
Significant reductions in functional mitral regurgitation as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.3 +13.8ml to 20.6 +12.4ml at 12 months (p<0.05)
80% of patients experienced at least a one class improvement in NYHA classification from baseline to 12 months
Marked improvement in functional capacity with six-minute walk distances, increasing from 294.1+82.6 to 381.6+130.3 metres at 12 months (p<0.01).
A low 30-day major adverse event rate of 2.8%.
“This enhanced version of the Carillon technology has performed superbly, demonstrating compelling outcomes and an impressive safety profile in an extremely sick patient population,” says Haude. “I was pleased to be able to present the results of the TITAN II trial to my cardiology colleagues at the TCT conference and am most encouraged by the fact that these positive outcomes are consistent with the previous two multi-centre evaluations of the Carillon system. With data from nearly 100 patients across three prospective trials, we have a conclusive basis from which to make the determination that Carillon should be a first-line treatment for patients suffering from functional mitral regurgitation.”