On 8 March, Cardiac Dimensions announced that it has completed enrolment in its TITAN II clinical trial, a follow-up to the landmark TITAN clinical trial of the company’s Carillon Mitral Contour System.
TITAN II is a prospective, single-arm European multicentre clinical trial initiated to further evaluate an enhanced version of the Carillon system. A novel, minimally-invasive therapy, the Carillon system is designed to treat heart failure patients suffering from functional mitral regurgitation.
The company announced that a total of 30 patients across five sites have been implanted with the Carillon system and will be followed for a one-year period as part of the TITAN II trial. Patients will be evaluated for improvements in mitral regurgitation, functional capacity, quality of life and reverse cardiac remodeling.
Published in the European Journal of Heart Failure, data from TITAN suggest that patients implanted with the Carillon system experienced significant relief from functional mitral regurgitation and improvements in functional capacity and quality of life compared to a contemporaneously-enrolled comparison group.
“The early clinical data from TITAN II is very promising,” said Rick Stewart, CEO, Cardiac Dimensions. “The implant rate increased substantially and the early data validate the impressive results that were observed in TITAN as well as reinforce the product enhancements we completed in 2011. We are most grateful to our investigators for their leadership throughout the study and look forward to the opportunity to present the complete TITAN II data set in the near future.”
The Carillon Mitral Contour System received the CE mark in October 2011.