Endosense has announced the release of acute clinical results from the TOCCATA (TOuCh+ for CATheter Ablation) European clinical trial at Heart Rhythm 2009, the Heart Rhythm Society’s 30th Annual Scientific Sessions in Boston, May 13 – 16. The highly anticipated results of the 76-patient, multi-center study confirm the feasibility, safety and value of Endosense’s TactiCath force-sensing ablation catheter during catheter ablation.
The first and only force-sensing ablation catheter, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The TactiCath was granted the CE mark in May 2009.
The TOCCATA trial was designed to evaluate the safety and value of force-sensing in the catheter ablation procedure. Conducted at eight centers in five countries, the study was led by Principal Investigator Karl-Heinz Kuck, M.D. with participation from 20 additional highly experienced investigators. Enrollment in TOCCATA was completed in February 2009, with a total of 76 patients (42 right SVT and 34 paroxysmal atrial fibrillation [AF]). Safety and treatment efficacy have been proven for the SVT group, which has reached the study endpoints. Data from the AF group is anticipated by the end of May.
During the study, operators were given full access to real-time force information during catheter ablation but were blinded to force information during force assessment. Key findings, extracted from 185 hours of force contact data, are the subject of two separate Heart Rhythm 2009 presentations by Dr. Kuck and TOCCATA investigator Dipen Shah, M.D.
These unique findings, based on the first comprehensive analysis of the clinical practice among several very experienced operators, confirm the results of Endosense’s extensive pre-clinical testing of the TactiCath. Of note, TOCCATA investigators discovered:
– A remarkably high variability of contact force application across even very experienced operators, suggesting the critical need for an accurate and reliable tool to measure contact force during the procedure;
– 12 percent of lesions created during the AF ablation procedure with a force of less than five grams, with half of these forces being intermittent. This suggests that contact force control may help reduce the approximate 30 percent re-intervention rate for AF catheter ablation; and
– A significant number of cases in which transient forces greater than 100 grams were exhibited during catheter manipulation. This is important, as pre-clinical studies have indicated that the ability to maintain more moderate levels of force may decrease the risk of complications.
“The first TOCCATA results are significant for Endosense, as they validate our pre-clinical data and also clearly demonstrate the numerous important benefits of contact-force sensing during catheter ablation,” said Eric Le Royer, president and chief executive officer, Endosense. “The data also reinforces the TactiCath’s potential to be the standard-setting technology solution for contact force measurement, moving us closer to our goal of enabling the widespread adoption of catheter ablation.”
The two TOCCATA abstracts highlight Endosense’s continuous commitment to developing the clinical science behind the TactiCath. Since Heart Rhythm 2006, ten abstracts have been developed on the company’s clinical research activities, based on the seminal work of Hiroshi Nakagawa, M.D., Ph.D. and Dr. Shah. This year, an additional abstract features the importance of the concept of force-time integral in lesion characterization.