Cardiac Dimensions announced that the first patient has been enrolled and successfully treated in the TITAN II clinical trial, a follow-up to the TITAN clinical trial of the Carillon mitral contour system.
TITAN II is a prospective, single-arm clinical trial initiated to further evaluate an enhanced version of the Carillon system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation.
During TITAN II, 30 patients across five sites will be implanted with the Carillon system and subsequently followed for a one-year period. The initial 53-patient TITAN clinical trial demonstrated significant relief from functional mitral regurgitation and improvements in functional capacity and quality of life compared to a contemporaneously-enrolled control group. The initial trial also demonstrated a low 30-day adverse event rate of 1.9%.
Michael Haude, Lukaskrankenhaus, Neuss, Germany, and TITAN II investigator commented, “We are excited to be involved in the TITAN II study, which comes on the heels of the landmark TITAN trial. This first patient presented with severe functional mitral regurgitation secondary to advanced heart failure, placing him at significant risk for early mortality and repeat hospitalisations. The Carillon device was easily deployed in a cath lab setting. Notably, we were able to confirm safety and benefit to the patient intra-operatively. The novel Carillon technology presents an attractive option for this patient’s condition and the millions of others who suffer similarly from heart failure. Collaborating with the other investigational sites in completing enrolment in the TITAN II trial will allow the broader clinical community to obtain a robust understanding of this nascent and exciting technology.”
About Carillon mitral contour system
Carillon combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilizing the heart’s natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation.