May 10 2010
Endosense, a Swiss medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced it has enrolled the first patients in EFFICAS I, the first study of the EFFICAS series. These patients were enrolled in Na Homolce Hospital, Prague, Czech Republic and treated by Petr Neuzil, M.D. and Vivek Reddy, M.D.
“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 is a study series intended to demonstrate that the use of contact force control during cardiac ablation utilizing the company's TactiCath® force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor.
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. In EFFICAS I, physicians will perform the procedure with the TactiCath without having access to contact force measurements; however, the contact forces applied will be recorded. In EFFICAS II, physicians will 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 will 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.
Outcomes data from EFFICAS I and II will help in the design of future, larger, EFFICAS studies with clinical endpoints.
"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," said Karl-Heinz Kuck, M.D., Asklepios Klinik St. Georg, Hamburg. "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."
Added Eric Le Royer, president and chief executive officer of Endosense, "Unique in its focus and depth, the EFFICAS series will 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."
The TactiCath force-sensing ablation catheter and the TactiSys™ system are indicated for the treatment of atrial fibrillation (AF) and supraventricular tachycardia (SVT). BIOTRONIK is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the United States.
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