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February 6, 2026Circulation Arrhythmia and Electrophysiology2 citations

High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial

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SXShuanglun XieHLHengli LaiFJFengpeng Jia

Key Result

High-repetition nanosecond pulsed field ablation achieved 88.5% freedom from atrial arrhythmias at 12 months with 2.4% serious adverse events, mostly under local anesthesia.

Key Points

  • This study aims to evaluate the safety and efficacy of a high-repetition frequency nanosecond pulsed field ablation for treating paroxysmal atrial fibrillation over 12 months.
  • Conducted as a multicenter, single-arm trial across 11 centers in China.
  • Involved symptomatic drug-refractory patients aged 18 to 80 years.
  • Performed pulmonary vein isolation using a commercial nanosecond pulsed field ablation system.
  • Primary efficacy endpoint measured freedom from atrial fibrillation or related conditions without antiarrhythmic drugs.
  • 162 out of 166 enrolled patients completed the follow-up.
  • Achieved 100% success in acute pulmonary vein isolation.
  • 88.49% of patients met the primary efficacy endpoint after 12 months.
  • No device- or procedure-related deaths, strokes, or transient ischemic attacks occurred.
  • Procedure-related serious adverse events were limited to 2.41% of patients.

Structured PICO

Does high-repetition-frequency nanosecond pulsed field ablation safely and effectively prevent atrial arrhythmias in symptomatic drug-refractory patients with paroxysmal atrial fibrillation?

P
Population
166 symptomatic drug-refractory patients with paroxysmal atrial fibrillation aged 18 to 80 years
I
Intervention
Pulmonary vein isolation using a commercial high-repetition-frequency nanosecond pulsed field ablation system
O
Outcome
Primary efficacy: freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia ≥30 seconds from 91 to 365 days postablation without use of class I and III antiarrhythmic drugs. Primary safety: freedom from device- or procedure-related death, stroke, transient ischemic attacks, or other major complications during the procedure and 12-month follow-up.composite

High-repetition-frequency nanosecond pulsed field ablation is highly effective and safe for paroxysmal atrial fibrillation, uniquely allowing most procedures to be performed under local anesthesia and conscious sedation.

Abstract

BACKGROUND: Nanosecond pulsed field ablation, which offers potential benefits, such as reduced muscle contraction, may enable procedures to be performed under local anesthesia.To evaluate the 12-month safety and efficacy of a novel high-repetition frequency nanosecond pulsed field ablation for treating paroxysmal atrial fibrillation. METHODS: The prospective, multicenter, single-arm trial SCENA-AF study was conducted across 11 Chinese centers. Symptomatic drug-refractory patients with paroxysmal atrial fibrillation aged 18 to 80 years underwent pulmonary vein isolation using a commercial nanosecond pulsed field ablation system. The primary efficacy end point was freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia ≥30 seconds from 91 to 365 days postablation without use of class I and III antiarrhythmic drugs. The primary safety end point was freedom from device- or procedure-related death, stroke, transient ischemic attacks, or other major complications during the procedure and 12-month follow-up. RESULTS: Of the 166 enrolled patients who underwent the PFA procedures, 162 completed follow-up. Acute pulmonary vein isolation success was 100% for targeted veins. At 12 months, 88.49% (95% CI, 82.54%–92.50%) met the primary efficacy end point. No device- or procedure-related death, stroke, or transient ischemic attacks occurred. Notably, 92.77% of procedures were performed under local anesthesia and conscious sedation. Procedure-specific serious adverse events occurred in 2.41% of patients and were limited to access-site hematomas or pseudoaneurysms that resolved. No clinical hemolysis signs or symptoms were observed. CONCLUSIONS: The novel high-repetition-frequency nanosecond pulsed field ablation demonstrated high 12-month efficacy and a favorable safety profile for paroxysmal atrial fibrillation treatment. The ability to perform most procedures under local anesthesia with conscious sedation, with general anesthesia rarely needed, highlights a potential advantage of this technology. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov ; Unique identifier: NCT06039722.

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Cite This Study

Xie et al. (2026) studied this question. High-repetition nanosecond pulsed field ablation achieved 88.5% freedom from atrial arrhythmias at 12 months with 2.4% serious adverse events, mostly under local anesthesia.

synapsesocial.com/papers/698586118f7c464f23009e92https://doi.org/10.1161/circep.125.014236
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