Why the study?
Most pulsed field ablation technologies for atrial fibrillation use microsecond-scale pulses, whereas nanosecond pulses enable larger pulse amplitudes to project lesion depth without near-field thermal effects.
Does nanosecond pulsed field ablation improve freedom from atrial arrhythmia and provide durable lesions in patients with symptomatic paroxysmal atrial fibrillation?
Does nanosecond pulsed field ablation improve freedom from atrial arrhythmia and provide durable lesions in patients with symptomatic paroxysmal atrial fibrillation?
In a first-in-human study, nanosecond pulsed field ablation for paroxysmal atrial fibrillation demonstrated 91% lesion durability and 89.7% freedom from atrial arrhythmia at 1 year, with a 1.7% rate of serious adverse events.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“It is well accepted that achieving durable PVI is essential for enhancing long-term freedom from atrial arrhythmia recurrence. With the nsPFA catheter, we observed good PVI durability, both acutely and at [three]-month invasive remapping, particularly when using [five]-second pulses.”
“These 12-month results are genuinely impressive. The durability of pulmonary vein isolation combined with the procedural efficiency we're seeing is not something we typically expect together at this stage of development. The consistency across patients and sites is particularly striking.”
“Our Cardiac Catheter continues to demonstrate durable pulmonary vein isolation with highly consistent long-term outcomes and an efficient procedural workflow. The procedural efficiency we are seeing across 12 months of follow-up well exceeds my expectations, and reinforces the potential of nsPFA technology to meaningfully advance the field of atrial fibrillation ablation.”
Should not yet change AF ablation practice; leaves open the durability and role of nsPFA pending larger trials.
BACKGROUND: Most pulsed field ablation (PFA) technologies for atrial fibrillation use microsecond-scale pulses. Nanosecond pulses, by virtue of their short duration, enable larger pulse amplitudes to project lesion depth, without near-field thermal effects. OBJECTIVES: The goal of this study was to determine the outcomes of treating paroxysmal atrial fibrillation using a novel circular nanosecond PFA (nsPFA) catheter. METHODS: In a first-in-human study of patients with symptomatic paroxysmal atrial fibrillation, the nsPFA catheter was used to deliver 2.5-second or 5-second applications. Invasive remapping assessed lesion durability at 2 to 3 months, with additional nsPFA for incomplete lesions. Follow-up included transtelephonic monitoring and Holter monitoring at 6 and 12 months. RESULTS: At 3 centers, 177 patients (mean age 61 ± 10 years; 36% female; left atrial diameter 41 ± 5 mm) underwent pulmonary vein isolation (PVI) using 2.5-second (n = 36 patients) or 5-second (n = 141) applications. Additional ablation was at the posterior wall (n = 87), cavotricuspid isthmus (n = 11), or mitral isthmus (n = 29). All (100%) lesions were acutely successful, with transpired PVI time of 12 ± 5 minutes, and total left atrial dwell time for the nsPFA catheter of 19 ± 13 minutes. Total procedure and fluoroscopy times were 61 ± 27 minutes and 9 ± 6 minutes, respectively. Three (of 177 [1.7%]) primary serious adverse events occurred: inflammatory pericardial effusion, hemolysis with acute kidney injury, and stroke. Post procedure brain magnetic resonance imaging (35 patients) revealed 11.4% silent cerebral events (DWI+ / ADC-reduced) and 11.4% silent cerebral lesions (SCE plus FLAIR+). PVI durability with the 5-second applications was 91%. The 1-year estimate for freedom from atrial arrhythmia was 89.7% (95% CI: 80.5%-94.6%). CONCLUSIONS: nsPFA demonstrated reasonable safety, good lesion durability, and favorable 1-year clinical effectiveness. (Evaluation of the CellFX® Nano-Pulsed Field Ablation [PFA] 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation. NCT06696170).
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Reddy et al. (2026) studied this question.
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