Arrhythmias & electrophysiologyResearch article
High-Voltage Nanosecond Pulse Field Ablation Using a Compliant Circular Catheter to Treat Atrial Fibrillation
- first-in-human study
- 3 centers
Authors' conclusion
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).
Study context
- Population
- Patients with symptomatic paroxysmal atrial fibrillationunderwent pulmonary vein isolation (PVI) · 2.5-second applications 36 · 5-second applications 141
- Participants
- 177 patients
- Comparison
- 2.5-second applications vs 5-second applications
- 2.5-second applicationsn = 36
- 5-second applicationsn = 141
Main finding
As reported in the abstract
Acute lesion success
All lesions acutely successful
100%
Further findings
- PVI durability with 5-second applications · 2 to 3 months
- 91%
Freedom from atrial arrhythmia · 1 year
- 1-year estimate for freedom from atrial arrhythmia
- 89.7% (95% CI: 80.5%-94.6%)
Additional ablation sites
- Posterior wall
- n = 87
- Cavotricuspid isthmus
- n = 11
- Mitral isthmus
- n = 29
Procedural times
- Transpired PVI time
- 12 ± 5 minutes
- Total left atrial dwell time for the nanosecond PFA (nsPFA) catheter
- 19 ± 13 minutes
- Total procedure time
- 61 ± 27 minutes
- Fluoroscopy time
- 9 ± 6 minutes
Safety
Primary serious adverse events
- Primary serious adverse events
- Three (of 177 [1.7%])
- Inflammatory pericardial effusion
- Hemolysis with acute kidney injury
- Stroke
Post procedure brain MRI findings (35 patients)
- Silent cerebral events (DWI+ / ADC-reduced)
- 11.4%
- Silent cerebral lesions (SCE plus FLAIR+)
- 11.4%
- among 35 patients with post procedure brain magnetic resonance imaging
Original publication
High-Voltage Nanosecond Pulse Field Ablation Using a Compliant Circular Catheter to Treat Atrial Fibrillation. JACC Clin Electrophysiol. Published 25 April 2026. doi:10.1016/j.jacep.2026.04.012
Summarised from the published abstract; every number is checked against it