Hansen Medical, developer of robotic technology for accurate 3D control of catheter movement, has initiated ERASE-VT, a clinical trial designed to evaluate its flexible catheter Sensei X robotic system in patients with ventricular tachycardia.
The Sensei X robotic system features a flexible catheter with remotely steerable distal tips designed to simplify and enhance catheter navigation and therapeutic intervention. The Early robotic ablation by substrate elimination of ventricular tachycardia study (ERASE-VT), is planned to enrol 200 patients with implantable cardioverter defibrillators (ICDs) at up to eight sites in Europe. The first patient has been enrolled by Prapa Kanagaratnam, electrophysiologist and the study’s principal investigator, St Mary’s Hospital, London.
The primary endpoint of the study is to reduce or eliminate episodes of VT, and the secondary endpoints are to evaluate the effects of robotic ablation on patient hospital length of stay, mortality, and quality of life. The patient follow-up is two years. The study is being sponsored by Imperial College of Science Technology and Medicine out of the Cardiology Department at St Mary’s Hospital, London, UK.
Kanagaratnam commented, “Our unit has already demonstrated the ability of the flexible catheter Sensei X robotic system to improve radiofrequency lesion quality through greater catheter stability and precision compared to the conventional manual approach. As the mechanism of ischaemic ventricular tachycardia is well understood, we believe that this arrhythmia is particularly suited to translating these advantages to clinical improvements for patients. We have already had a number of cases that were successful with the Sensei X robotic system that had previously failed with a conventional ablation approach. Therefore, we are very excited to work with Hansen Medical and the leading robotic centres in Europe to evaluate their products in a clinical trial testing the novel clinical indication of robotic ablation after the first episode of ventricular tachycardia in patients with an ICD versus conventional medical therapy.”
“We are pleased to provide financial support of this physician-driven study as further evidence of our commitment to developing innovative products that provide clinical improvements for our electrophysiology customers and their patients,” said Bruce Barclay, Hansen Medical’s president and CEO. “Based on the early clinical feedback, we believe that flexible robotics from Hansen Medical have the potential to provide benefits not available with conventional manual catheter ablation, and we look forward to generating the data necessary to develop this new application for our products.”