Endosense has invested in a comprehensive clinical research program to further validate its TactiCath force-sensing ablation catheter. Studies include the following.
Launched in January 2011, TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) is a prospective, randomized, multi-center interventional study to evaluate the safety and effectiveness of the TactiCath force-sensing ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation. The study, led by Principal Investigator Vivek Reddy, MD of Mount Sinai Medical Center in New York, will enroll up to 400 patients at centers in the United States and Europe. Eligible subjects must be 18 or older and suffer from AF that is poorly managed with drugs. Half of all subjects will receive treatment with the TactiCath force-sensing ablation catheter and half with a conventional ablation catheter.
The TOCCASTAR clinical study is being conducted at qualified research institutions across the United States and Europe.
The EFFICAS Study Series
Launched in May 2010, EFFICAS is a study series intended to demonstrate that the use of contact force control during cardiac ablation utilizing the TactiCath force-sensing catheter results in superior clinical outcomes as compared to ablations performed without a force sensor. EFFICAS I and EFFICAS II are single arm, multi-center, prospective pilot studies that will assess the clinical effectiveness of catheter ablation with and without the use of contact force control. Outcomes data from EFFICAS I and II will help in the design of future, larger, EFFICAS studies with clinical endpoints.
Launched in late 2008, TOCCATA (TOuCh+ for CATheter Ablation) was a multi-center, prospective safety and performance study led by Principal Investigator Karl-Heinz Kuck, M.D., with the participation of 21 highly experienced investigators. 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. In 12-month data presented during the Heart Rhythm 2011, 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 (p<0.05) 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).