Abstract
Background: Advanced irrigated catheters, such as the FlexAbility™ Ablation Catheter, Sensor Enabled™ (FlexAbility SE), improve safety during RF ablation. Integration of contact force sensing technology with FlexAbility SE is clinically desirable to further enhance procedural efficacy and safety. Objective: To compare lesion size and adverse events in a perfused porcine thigh model for the TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) and its market-released predecessor, FlexAbility SE. Methods: Power controlled RF ablations were performed in 5 swine at either a nominal (30W, 60s; N=88) or maximum (50W, 10s; N=74) setting (20 g, 13 ml/min irrigation rate for all). Trials were balanced between parallel and perpendicular tip orientations. Coagulum formation, steam pops, char and lesion depth and width were documented. At each setting, lesion depth and width were assessed for equivalence between catheters (linear mixed model). Results for both orientations were pooled and adverse events were evaluated for non-inferiority of TactiFlex SE compared to FlexAbility SE (logistic regression). Results: Lesion depth and width were equivalent between TactiFlex SE and FlexAbility SE for all conditions (pre-specified- equivalence interval = ±1.67mm). TactiFlex SE was non-inferior to FlexAbility SE for rate of coagulum and char (pre-specified upper -non-inferiority margin = 20% ). No steam pops occurred with either catheter. Conclusion: The TactiFlex™ Ablation Catheter, Sensor Enabled™ produced equivalent lesion sizes and a favorable adverse event profile when compared to the FlexAbility™ Ablation Catheter, Sensor Enabled™ in a perfused porcine thigh model.
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