A novel radiofrequency ablation catheter using contact force sensing: Toccata study

OBJECTIVES The aim of this multicenter study was to evaluate the device-and procedure-related safety of a novel force-sensing radiofrequency (RF) ablation catheter capable of measuring the real-time contact force (CF) and to present CF data and its possible implications on patient safety. BACKGROUND The clinical outcome of RF ablation for the treatment of cardiac arrhythmias may be affected by the CF between the catheter tip and the tissue. Insufficient CF may result in an ineffective lesion, whereas excessive CF may result in complications. METHODS Seventy-seven patients (43 with right-sided supraventricular tachycardia [SVT] and 34 with atrial fibrillation [AF]) received percutaneous ablation with the novel studied catheter. The CF applied and safety events related to the procedure were reported. RESULTS CF values at mapping ranged from 8 +/- 8 to 60 +/- 35 g and from 12 +/- 10 to 39 +/- 29 g in the SVT group and the LA group, respectively, showing a significant interinvestigator variability (P < .0001). High transient CFs (>100 g) were noted in 27 patients (79%) of the LA group. One device-related complication (tamponade, 3%) occurred in the AF group. CONCLUSIONS Catheter ablation using real-time CF technology is safe for the treatment of SVT and AF. High CFs may occur during catheter manipulation and not just during ablation, suggesting that measuring CF may provide additional useful information to the operator for safe catheter manipulation. In the future, CF-sensing catheters may also increase the effectiveness of RF ablations by allowing better control of the RF lesion size.