Endosense completes enrolment in EFFICAS I clinical study


Endosense announced enrolment completion in the EFFICAS I clinical trial. EFFICAS is a study series intended to demonstrate that, in patients with paroxysmal atrial fibrillation (AF), the use of contact force control during cardiac ablation utilising the company’s TactiCath force-sensing catheter1 results in superior outcomes as compared to ablations performed with a standard catheter.

EFFICAS I is a 45-patient, single-arm, prospective, multicentre European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation and atrial fibrillation treatment efficacy at three months. The endpoint for the study is the occurrence of reconduction areas in the pulmonary vein isolation 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 pulmonary vein isolation lines. Contact force parameters from initial procedures are then analysed to determine the relationship with lesion formation.

“The EFFICAS studies represent a scientifically rigorous approach to quantifying the importance of contact force in catheter ablation,” said Karl-Heinz Kuck, Asklepios Klinik St. Georg, Hamburg, Germany, “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 next study in the EFFICAS series is EFFICAS II, in which investigators will take full advantage of the real-time, objective TactiCath contact force control features to improve their ablation technique during lesion creation. Endpoints for EFFICAS II will include reduction in pulmonary vein isolation gaps as compared to EFFICAS I. Outcomes data from EFFICAS I and II will help in the design of future, larger EFFICAS randomised studies with clinical endpoints. EFFICAS II enrolment is currently underway.

The TactiCath force-sensing ablation catheter and the TactiSys system are indicated for the treatment of AF and supraventricular tachycardia. Biotronik is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available for sale in the United States.