Endosense, a Swiss medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has enrolled the first patients in Efficas I, the first study of the Efficas series.
Endosense said that the patients were enrolled in Na Homolce Hospital, Prague, Czech Republic and treated by Petr Neuzil and Vivek Reddy of Endosense.
Endosense said that Efficas is a study series intended to demonstrate that the use of contact force control during cardiac ablation utilising the company’s TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor.
Endosense claimed that Efficas I and Efficas II are single arm, multi-center, prospective pilot studies that will assess the effectiveness of catheter ablation with and without the use of contact force control.
Additionally, in Efficas I, physicians are expected to perform the procedure with the TactiCath without having access to contact force measurements, however, the contact forces applied are expected to be recorded.
Reportedly, in Efficas II, physicians are expected to take full advantage of the TactiCath contact force control features, with the ability to objectively influence their ablation technique during lesion creation. The endpoint for Efficas I is expected to be the occurrence of reconduction areas in the pulmonary vein isolation (PVI) lines, relative to the contact forces applied, endpoints for Efficas II will include reduction in PVI reconduction as compared to Efficas I.
Karl-Heinz Kuck, MD of Asklepios Klinik St Georg at Hamburg, said: “The Efficas study series represents a very rigorous and thoughtful approach to evaluating the comparative clinical effectiveness of contact force control in the catheter ablation treatment of cardiac arrhythmias.
“Efficas I and II will lay an important foundation for achieving this goal while also yielding valuable incremental insights that can be immediately applied to current clinical practice.”
Eric Le Royer, president and CEO of Endosense, said: “The Efficas series is expected to provide a definitive measure of the clinical value and superiority of force control in the catheter ablation treatment of cardiac arrhythmias.
“These studies add to a growing library of robust clinical research designed to establish uncompromising scientific validation of the TactiCath. We are confident that this validation will make contact force control the standard of care in the electrophysiology lab.”