Arrhythmias & electrophysiologyRandomised controlled trial
Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation
- Randomised controlled trial
- prospective
- multicentre
- non-inferiority
Authors' conclusion
The nsPFA exhibited noninferior efficacy and comparable safety to AI-guided RFA while obviating the need for general anesthesia.
Study context
- Population
- Patients with paroxysmal AF, 13 centres in China13 centres in China
- Participants
- 287 patients
- Comparison
- Nanosecond pulsed field ablation (nsPFA) vs ablation index (AI)-guided radiofrequency ablation (RFA) for pulmonary vein isolation
- Primary endpoint
- Freedom from documented atrial tachyarrhythmia recurrence without class I or III antiarrhythmic drugs
- Follow-up
- 12 months
Primary result
As reported in the abstract
Adjusted rate difference
2.0%
95% CI −8.7% to 12.8%
P = 0.0019 for non-inferiority
Events by treatment group
nsPFA vs AI-guided RFA
adjusted rate difference 2.0% (95% CI −8.7% to 12.8%); P for non-inferiority = 0.0019
Secondary outcomes
| Outcome | nsPFA | AI-guided RFA | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| 12-month Kaplan-Meier treatment success | 66.7% | 67.4% | 0.99 (0.66–1.48) | P for non-inferiority = 0.0020 | |
| 0.512Hazard ratio (log scale) |
Acute procedural success
Procedural measures
- nsPFA: significantly shorter total procedure time, left atrial dwell time and ablation time; longer fluoroscopy times and higher radiation exposure doses
Safety
Procedure-related adverse events
- No significant difference between the 2 groups
Original publication
Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. Published 9 December 2025. doi:10.1016/j.jacc.2025.09.1593
Summarised from the published abstract; every number is checked against it