Background: AF catheter ablation using thermal energies is associated with indiscriminate tissue destruction. Pulsed field ablation (PFA) with adapted sub-second electric – fields create pores in cell membranes – caused irreversible electroporation.
Method:
The study catheter (EasyPulzTM, BTL) features a compressible mesh basket, allowing creation of 8 to 32 mm circular lesions. The tip has 32 independently addressable electrodes for electrogram assessment.
F-I-H clinical study is designed as a prospective, non-randomized, open-label, single arm, clinical safety and feasibility study. Single shot PF application per two positions per PV.Isolation of target was confirmed using CARTO (Biosense Webster Inc) and exit block testing.A remapping procedure is performed at the Day-90 visit to assess the durability of ablation lesions. At investigator discretion, additional lesions may be made using the investigated system to optimize outcomes of the subjects.
Results:
To date, 17 patients have undergone the index procedure in single center. No predefined primary safety events have occurred, and no delayed hospital discharges were observed. Acute PVI was achieved in 100% of cases (71/71). The posterior wall was ablated in four cases, all with acute success (4/4).The catheter enables circular contact with the ostia of veins of various diameters and shapes, with good fluoroscopic visibility. Additionally, the numerous electrodes on the basket facilitate reliable tissue contact verification.
Conclusion:
The new PFA system with expandable mesh catheter can achieve acute PV electrical isolation of the targeted veins, usually within a single catheter position. Durability of the PFA Multi electrode basket catheter will be evaluated
