Limitations
Assignment of study patients into each ablation group was performed in a randomized but unblinded manner. However, despite the operators being aware of the catheter type used during the PVI procedure, the ablation technique was not modified either with the novel SF® or the standard Thermocool® catheter. Further, procedural data comparison for each single operator, revealed higher efficiency of SF® versus TC® for each operator (data not shown).
The clinical follow-up performed in our study could result in underestimation of the real incidence of clinical AF recurrence in both groups. However, this study was mainly designed to compare the acute procedural efficiency and safety between the standard TC® and the novel SF® catheters.