- Question
- Is pulsed field ablation noninferior to conventional thermal ablation (radiofrequency or cryoballoon) in patients with drug-refractory paroxysmal atrial fibrillation?
- Design
- Randomized, single-blind, noninferiority trial with 1:1 allocation. A total of 305 patients were assigned to pulsed field ablation and 302 to thermal ablation; the primary endpoints were assessed at 1 year.
- Population
- Patients with paroxysmal atrial fibrillation refractory to antiarrhythmic drugs who were candidates for catheter ablation.
- Intervention
- Pulmonary vein isolation using pulsed field ablation, which delivers microsecond high-voltage electrical fields.
- Control
- Conventional thermal ablation with either radiofrequency or cryoballoon ablation.
- Primary outcome
- Efficacy: freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation. Safety: acute and chronic device- and procedure-related serious adverse events.
- Results
- At 1 year, the primary efficacy end point was met in 204 patients (estimated probability, 73.3%) with pulsed field ablation and 194 patients (estimated probability, 71.3%) with thermal ablation (difference, 2.0 percentage points; 95% Bayesian credible interval, -5.2 to 9.2; posterior probability of noninferiority, >0.999).
- Safety
- Primary safety end-point events occurred in 6 patients (estimated incidence, 2.1%) with pulsed field ablation and 4 patients (estimated incidence, 1.5%) with thermal ablation; noninferiority was also met (posterior probability, >0.999).
- Conclusion
- In paroxysmal atrial fibrillation, pulsed field ablation was noninferior to conventional thermal ablation for both efficacy and safety at 1 year.
- Why it matters
- It provided the first randomized evidence that a nonthermal energy source can match established thermal techniques, paving the way for clinical adoption of pulsed field ablation in atrial fibrillation.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026