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news.Endosense, a medical technology company, has launched the Toccata clinical study to evaluate the safety of the TactiCath system with enrollment gaining momentum.
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Toccata is a 70 patient European multi-center safety study. Constructed to gain the CE Mark for the treatment of atrial arrhythmias, secondary endpoints were designed to evaluate the value of force-sensing in successfully impacting outcomes of the ablation procedure.
The start of this clinical trial marks the first use of the TactiCath force-sensing catheter in patients. The patients treated to date have had different arrhythmia pathologies, including atrial fibrillation. With TactiCath, physicians can be assured they are using the optimal contact force for the appropriate lesion creation in a catheter ablation procedure, the company said.
TactiCath is the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It has the potential to impact safety and performance of the catheter ablation treatment of cardiac rhythm disorders, including atrial fibrillation.
Pr Kuck, principal investigator of Toccata, said: “The first Toccata patients had their arrhythmia successfully treated at acute follow-up. The physicians’ experiences have shown the tremendous potential of force-sensing to the clinical practice, and we’re hopeful that the results will reinforce our initial findings.”