Visualization of PFA During PVI With the Second-Generation Pentaspline Catheter: NAVIGATE-PF Phase 1 Results

Pulsed field ablation (PFA) for atrial fibrillation ablation provides a unique challenge for acute lesion evaluation due to reversible myocardial injury. Real-time guidance during ablation would provide reference for lesion location and extent. The second-generation pentaspline PFA catheter improves mapping integration with real-time visualization of catheter shape and previews the estimated ablative electric field.

This study sought to evaluate the estimated shape and position of the acute tags relative to low-voltage borders from high-density, postablation maps.

A multicenter, first-in-human study, NAVIGATE-PF (Feasibility Study on the FARAVIEW Technology), was conducted in 30 atrial fibrillation patients. Tags were placed following each application based on the shape of the estimated electric field. Post ablation, a high-quality, high-density voltage map was created with a high-density mapping catheter. Tags were overlaid on the high-density map and contours were drawn at the border of low voltage (≤0.5mV) and the outer border where at least 2 overlapping tags were placed.

All 30 patients were successfully treated with the second-generation PFA catheter. For the 15 patients included in the acute tags analysis, the region of acute electrical isolation correlated with the estimated ablative electric field. Post-procedural processing of the distance between the tag and low-voltage border was -0.58 mm (Q1-Q3: -2.9 to 2.17 mm) where a negative number indicates the tag is smaller than the low-voltage border.

The second-generation pentaspline PFA catheter, with dynamic shape visualization and preview of anticipated electric field, resulted in alignment with postablation voltage mapping. (Feasibility Study on the FARAVIEW Technology [NAVIGATE-PF]; NCT06175234).