Study endpoints

The primary endpoint was procedural time, defined as the duration from femoral venous puncture to the extraction of catheters from the left atrium.

Secondary endpoints included measures of procedural efficiency, clinical efficacy at 6 months, safety, and the durability of the lesions in patients undergoing repeat procedures.

Procedural efficiency was assessed based on fluoroscopy dose and high-sensitivity troponin I level on Day 1 (Atellica® IM TnIH assay on lithium–heparin plasma, Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA), while clinical efficacy was defined as the freedom from ATA following a single procedure during the 6-month follow-up period.

Safety outcomes were determined by evaluating the incidence of primary adverse events occurring within the first 7 days post-ablation. These adverse events included, but were not limited to, death, cerebrovascular accident, myocardial infarct, atrio-oesophageal fistula, cardiac tamponade or perforation, and PV stenosis. The occurrence of PV stenosis or atrio-oesophageal fistula beyond 7 days was also considered a primary adverse event.

The durability of the lesions was evaluated in patients with recurrence who underwent repeat procedures.