St. Jude Medical Thursday announced positive results from the first prospective, randomized TOCCASTAR clinical trial of contact-force ablation technology for the treatment of paroxysmal atrial fibrillation.
The multicenter, noninferiority trial followed 300 U.S. and European patients through 12 months of follow-up, meeting its primary endpoints, the company reported at the Heart Rhythm Society's 35th Annual Scientific Sessions in San Francisco.
Results showed that the TactiCath irrigated ablation catheter exceeded the safety and efficacy endpoints by 5.9 percent and 4.3 percent, respectively, based on a 95 percent confidence interval, St. Jude said.
Of patients treated optimally with contact-force ablation therapy via the TactiCath catheter, 75.9 percent were also free from paroxysmal atrial fibrillation at the end of the follow-up period. This compared with 58.1 percent of patients who did not receive the optimal 10 grams or more of force during ablation procedures, St. Jude noted.
"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," said Vivek Reddy, director of electrophysiology at Mount Sinai Hospital.
St. Jude spokeswoman Kate Stoltenberg said the company submitted a premarket approval application for the contact-force ablation technology in the fourth quarter of 2013. — Kellen Owings
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