St Jude Medical has unveiled the clinical results of TOCCASTAR clinical trial, a multicentre, non-inferiority study, at Heart Rhythm 2014 in San Francisco, US.
The multicentre, non-inferiority study evaluating 300 patients in the US and Europe, has met primary endpoints and the results supplement the growing body of evidence that supports the safety and effectiveness of contact-force ablation technology.
The first prospective, randomised study of contact-force ablation technology for treatment of paroxysmal atrial fibrillation (AF) followed device performance and assessed patient outcomes through 12 months of follow-up.
Based on a 95% confidence interval, the TactiCath irrigated ablation catheter has exceeded the safety and efficacy non-inferiority benchmarks set out in the trial by 5.9% and 4.3%, respectively.
Approximately 75.9% of patients 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 10g 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 10g of force or more during ablation procedures.
Mount Sinai Hospital, New York director of electrophysiology Dr Vivek Reddy said 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.
"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," Dr Reddy said.
St Jude Medical vice-president of medical and scientific affairs, global clinical affairs Dr 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," Dr Mahapatra said.
The TactiCath irrigated ablation catheter offers physicians a real-time, objective measure of the force applied to the heart wall during a catheter ablation procedure.
The EnSite Velocity system, a cardiac mapping and navigation system, displays that data produced by the TactiCath irrigated ablation catheter via the EnSite contact force module.
According to St Jude Medical, the CE-marked EnSite contact software module integrates contact-force ablation technology and 3D mapping and navigation capabilities. The EnSite contact force module is not approved for use in the US.
The study has been conducted to gather data in support of US Food and Drug Administration (FDA) approval and is the basis for the company's premarket approval (PMA) submission that has been filed with the FDA.
TactiCath has received CE Mark approval and is commercially available in Europe. In the US, TactiCath is available for investigational use only.
Image: St Jude Medical Global Headquarters. Photo: courtesy of St Jude Medical, Inc.