Arrhythmias & electrophysiologyRandomised controlled trial
Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation
- Randomised controlled trial
- single-blind
- non-inferiority
Authors' conclusion
Among patients with paroxysmal atrial fibrillation receiving a catheter-based therapy, pulsed field ablation was noninferior to conventional thermal ablation with respect to freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation and with respect to device- and procedure-related serious adverse events at 1 year.
Study context
- Population
- Patients with drug-refractory paroxysmal AF
- Participants
- 305 vs 302
- Comparison
- Pulsed field ablation vs conventional thermal ablation
- Pulsed field ablationn = 305
- Thermal ablationn = 302reference
- Primary endpoint
- Freedom from a composite of:
- Initial procedural failure
- Documented atrial tachyarrhythmia after a 3-month blanking period
- Antiarrhythmic drug use
- Cardioversion
- Repeat ablation
- Follow-up
- 1 year
Primary result
Primary efficacy end point met (no events)
Between-group difference
2.0 percentage points
95% CrI −5.2 to 9.2
Events by treatment group
As reported in the abstract
Safety
Estimated incidence
| Outcome | Pulsed field ablation | Thermal ablation | between-group difference (percentage points) (95% CrI) | |
|---|---|---|---|---|
| Primary safety end point: acute and chronic device- and procedure-related serious adverse events · posterior probability of noninferiority >0.999 · Bayesian CrI · non-inferiority met | 2.1% | 1.5% | 0.6 (−1.5 to 2.8) | |
| −2024Difference, percentage points (linear scale) |
Original publication
Summarised from the published abstract; every number is checked against it