Endosense has released 12-month data from the TOCCATA (TOuCh for CATheter Ablation) study that further reinforce the potential of the TactiCath force-sensing ablation catheter to improve clinical outcomes in the treatment of cardiac arrhythmia by catheter ablation.
TOCCATA was an eight-center, prospective study designed to evaluate the safety and effective performance of the TactiCath. Investigators used the TactiCath to perform catheter ablations on 76 patients, including 34 with paroxysmal atrial fibrillation. Primary safety and performance endpoints were met during the course of the study. The study was led by principal investigator Karl-Heinz Kuck, with the participation of 21 additional experienced investigators.
In the new data presented during Heart Rhythm 2010, TOCCATA abstract authors suggested room for a safer and more effective catheter ablation treatment in the future, as retrospective analysis identified a statistically significant relationship between the contact force applied at ablation sites and the 12-month success of the procedure (median contact force applied in the non-recurrent patient group was 20g versus 11g in the recurrent patient group).
The data was reported in a clinical abstract at Heart Rhythm 2010, the Heart Rhythm Society’s 31st Annual Scientific Sessions in Denver.
Eric Le Royer, president and chief executive officer of Endosense, said: “The 12-month results offer a very promising perspective on the TactiCath’s ability to improve clinical outcomes in the catheter ablation treatment of cardiac arrhythmias.
“Endosense was founded to help physicians and patients realize the great potential of safe and effective catheter ablation, and we continue to deliver on that mission with this remarkable and unique data.
“Building on the success of TOCCATA, we are supporting the launch of several, additional groundbreaking studies over the course of 2010, a move that further reinforces Endosense’s leadership position in the field.”
Endosense is focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias.