US-based St. Jude Medical has reported results of the first prospective, randomized TOCCASTAR clinical trial of contact-force ablation technology for the treatment of paroxysmal atrial fibrillation (AF)
The trial met primary endpoints and supplements the growing body of evidence that supports the safety and effectiveness of contact-force ablation technology.
Results of the trial were announced at Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco.
Mount Sinai Hospital director of electrophysiology Vivek Reddy said the results from the TOCCASTAR trial further demonstrate the strong safety and efficacy profile of the TactiCath irrigated ablation catheter for the treatment of atrial fibrillation.
"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," Reddy said.
The multicenter, non-inferiority TOCCASTAR trial is evaluating 300 patients in the US and Europe.
The company said that 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.
The results showed that the TactiCath Irrigated Ablation Catheter exceeded the safety and efficacy non-inferiority benchmarks set forth in the trial by 5.9% and 4.3%, respectively, based on a 95% confidence interval.
Additionally, around 75.9% 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% of patients who did not receive 10 grams or more of force.
Optimal contact-force parameters for the TactiCath catheter has been defined as 10 grams of force or more during ablation procedures, according to previous studies, including TOCCATA, EFFICAS I and EFFICAS II.
St. Jude Medical vice president of medical and scientific affairs, global clinical affairs Srijoy Mahapatra said results from the TOCCASTAR study represent an important step forward in contact-force ablation technologies.
"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 US," Mahapatra said.