Paroxysmal AF ablation: dual energy catheter demonstrates benefit at 12 months

The SmartfIRE study demonstrated that over 70% of patients were free from documented atrial arrhythmia recurrence at one year when treated with the DE STSF catheter for paroxysmal atrial fibrillation. Moreover, patients also experienced an improvement in quality of life and reductions in cardiovascular hospitalisations.

The SmartfIRE study (NCT05752487) is a prospective, interventional trial with a single-arm design, conducted to evaluate the safety and effectiveness of a dual energy (DE) focal contact force catheter, the DE STSF catheter. This device can deliver both radiofrequency (RF) and pulsed field (PF) energy. While the findings from the 3-month follow-up have been shared previously [1], the outcomes were observed over 12 months and presented during the EHRA meeting by Prof. Tom de Potter (Cardiovascular Research Centre Aalst, Belgium) [2]. Primary endpoints were reported at 3 months: At this time, there was a 100% acute procedural success with an incidence of primary adverse events (PAE) within seven days of the procedure of 4.4% [1]. All included patients had drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF).

At 12 months, 71.6% (96/134) of patients were free from symptomatic and asymptomatic atrial fibrillation (AF)/atrial flutter (AFL)/and atrial tachycardia (AT) recurrence. Thus, the performance goal was met.

The safety profile was acceptable: In the 12-months safety analysis, 5 serious adverse events were observed in 5 patients (3.6%). Of note, there was no PF energy-related event, coronary spasm, oesophageal injury, phrenic nerve injury, or haemolysis.

A post-hoc analysis demonstrated that effectiveness results were superior in patients with high adherence to recommended ablation parameters (maintaining an ITD≤6 mm in ≥95% of applications and achieving a target index of ≥400 posteriorly and ≥500 anteriorly in >70% of applications). They achieved a 12-month freedom from recurrence of 86.9%. As Prof. de Potter emphasised, patients experienced also a significant increase in quality of life and reductions in cardiovascular hospitalisation and antiarrhythmic drug use post-ablation.

1. De Potter T, et al. Safety, effectiveness, and healthcare benefits of a dual energy focal ablation technology to treat paroxysmal atrial fibrillation: SmartfIRE 12-month results. Late-breaking science 1, EHRA 2025, 30 March –01 April, Vienna, Austria.
2. Duytschaever M, et al. Europace 2024;26:euae088.

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Posted on 6 May 20256 May 2025