February 16, 2011 – Enrollment has been completed for a trial investigating a force-sensitive catheter during cardiac ablation. The EFFICAS study in intended to demonstrate that the TactiCath catheter, by Endosense, results in superior outcomes in patients with paroxysmal atrial fibrillation (AF).
EFFICAS I is a 45-patient, single-arm, prospective, multi-center European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI) and AF treatment efficacy at three months. The endpoint for the study is the occurrence of reconduction (or “gap”) areas in the PVI lines, relative to the contact forces applied during lesion formation. While investigators perform the procedure with the TactiCath, they are blinded to contact force measurements. However, the contact forces applied are recorded. Patients are re-assessed with a mapping catheter at three months to identify potential gaps in the PVI lines. Contact force parameters from initial procedures are then analyzed to determine the relationship with lesion formation.
“We believe that the data from EFFICAS I will greatly advance the scientific understanding of contact force and the role it plays in the catheter ablation treatment of AF, as the data will allow us to better identify those force parameters that will deliver optimal patient outcomes,” said Eric Le Royer, president and CEO of Endosense.
In the next study, investigators will take full advantage of the real-time, objective contact force control features to improve their ablation technique during lesion creation. Endpoints for EFFICAS II will include reduction in PVI gaps as compared to EFFICAS I. Outcomes data from EFFICAS I and II will help in the design of future, larger EFFICAS randomized studies with clinical endpoints. EFFICAS II enrollment is currently underway.
“The EFFICAS studies represent a scientifically rigorous approach to quantifying the importance of contact force in catheter ablation,” said Karl-Heinz Kuck, M.D., Asklepios Klinik St. Georg, Hamburg. “Never before have we looked at each ablation point with such level of detail. A preliminary analysis of the 24 patients who have completed their three-month follow-up indicates some truly groundbreaking findings. We look forward to communicating the results to our fellow electrophysiologists, as we believe these studies will result in actionable recommendations that will have a meaningful impact on catheter ablation effectiveness.”
The TactiCath force-sensing ablation catheter and the TactiSys system are indicated for the treatment of AF and supraventricular tachycardia (SVT).
For more information: www.endosense.com