St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results of the TOCCASTAR clinical trial at Heart Rhythm 2014, the Heart Rhythm Society’s 35 th Annual Scientific Sessions in San Francisco. Results from the first prospective, randomized study of contact-force ablation technology for the treatment of paroxysmal atrial fibrillation (AF) met primary endpoints and supplement the growing body of evidence that supports the safety and effectiveness of contact-force ablation technology.
“The findings from the TOCCASTAR trial further demonstrate the strong safety and efficacy profile of the TactiCath irrigated ablation catheter for the treatment of atrial fibrillation,” said Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Hospital, N.Y. “The results of this study have significant clinical relevance for optimal cardiac ablation therapy and provide compelling evidence that contact-force ablation procedures are effective in treating paroxysmal atrial fibrillation.”
The TOCCASTAR study is a multicenter, non-inferiority study evaluating 300 patients in the U.S. and Europe. The investigational device exemption (IDE) clinical trial, which followed device performance and assessed patient outcomes through 12 months of follow-up, met its primary safety and effectiveness endpoints. Results demonstrated that the TactiCath™ Irrigated Ablation Catheter exceeded the safety and efficacy non-inferiority benchmarks set forth in the trial by 5.9 percent and 4.3 percent, respectively, based on a 95 percent confidence interval. In addition, approximately 75.9 percent of the patients that were treated optimally with contact-force ablation therapy via the TactiCath catheter were free from paroxysmal AF at the end of the 12 month follow-up period, compared to 58.1 percent of patients who did not receive 10 grams or more of force. Through previous studies, including TOCCATA, EFFICAS I and EFFICAS II, optimal contact-force parameters for the TactiCath catheter has been defined as 10 grams of force or more during ablation procedures.
“Results from the TOCCASTAR study represent an important step forward in contact-force ablation technologies,” said Srijoy Mahapatra, M.D., vice president of medical and scientific affairs, global clinical affairs at St. Jude Medical. “We are confident our large and growing body of clinical evidence demonstrates that the use of contact-force ablation safely reduces the rate of AF recurrence and we look forward to making this important technology available to electrophysiologists in the U.S.”