A novel nanosecond pulsed field ablation (nsPFA) system has demonstrated noninferior efficacy and comparable safety to conventional ablation index (AI)-guided radiofrequency ablation (RFA) for treating paroxysmal atrial fibrillation (AF), according to results from the InsightPFA trial.¹ The study also highlights that the procedure can be performed under conscious sedation, potentially streamlining workflows.
The nsPFA system (Insight Medtech) is a non-thermal energy source that delivers ultra-short, high-voltage electrical pulses for pulmonary vein isolation (PVI). This approach aims to achieve tissue selectivity, creating durable lesions while minimising the risk of damage to surrounding structures. Unlike microsecond PFA systems, nsPFA is associated with fewer muscle contractions, reducing the need for general anaesthesia.
The InsightPFA trial (NCT06014996) was a prospective, multicentre, randomized, noninferiority trial conducted across 13 centres in China. The study enrolled 287 patients with symptomatic paroxysmal AF who were randomized on a 1:1 basis to undergo PVI with either the nsPFA system or AI-guided RFA.
The primary efficacy endpoint was freedom from documented atrial tachyarrhythmia recurrence (lasting ≥30 seconds) at 12 months, following a 3-month blanking period, without the use of class I or III antiarrhythmic drugs (AADs). The primary safety endpoint was a composite of procedure- and device-related adverse events.
The trial met its primary efficacy endpoint, with 65.5% of patients in the nsPFA group achieving freedom from atrial tachyarrhythmia compared to 64.1% in the RFA group (adjusted rate difference: 2.0%; 95% CI: -8.7% to 12.8%; p=0.0019 for noninferiority). The 12-month Kaplan-Meier success rates were similar between groups (66.7% for nsPFA vs 67.4% for RFA).
Acute procedural success was 100% in both arms. The nsPFA group had significantly shorter total procedure, left atrial dwell, and ablation times compared to the RFA group. However, fluoroscopy times and radiation exposure were higher with nsPFA. Notably, 89.4% of nsPFA procedures were completed under conscious sedation.
There was no significant difference in the incidence of procedure-related adverse events. No cases of procedure-related death, stroke, cardiac tamponade, or atrioesophageal fistula were reported in either group.
These findings position nsPFA as a viable alternative to thermal ablation for paroxysmal AF, offering similar efficacy and safety with the key advantage of shorter procedure times. The ability to perform the ablation under conscious sedation could also improve patient comfort and procedural efficiency. The study authors concluded that “nsPFA exhibited noninferior efficacy and comparable safety to AI-guided RFA while obviating the need for general anesthesia,” adding that the technique “significantly reduced both total procedure time and left atrial dwelling time.”¹
References
1. Lin W, Chu H, Wang C, et al. Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial. JACC. 2025;86(23):2314–26. https://doi.org/10.1016/j.jacc.2025.09.1593
2. Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. 2023;389:1660–71. https://doi.org/10.1056/NEJMoa2307291
This study was funded by Insight Medtech Co, Ltd.
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