Cohort study
Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED Atrial Fibrillation (AF) Pivotal Trial
- Prospective nonrandomised paired single-arm study
- global
- multicentre
Authors' conclusion
PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.
Study context
- Population
- Patients with symptomatic paroxysmal or persistent AF refractory to class I or III antiarrhythmic drugs, treated with pulsed field ablation
- Participants
- 150 vs 150
- Exposure
- Paroxysmal AF vs Persistent AF
- Paroxysmal AFn = 150
- Persistent AFn = 150
- Outcome
- Freedom from a composite of:
- Acute procedural failure
- Arrhythmia recurrence or antiarrhythmic escalation
- Excluding a 3-month blanking period
- Follow-up
- 12 months
Main finding
As reported in the abstract
Effectiveness (Kaplan-Meier) · 1 year
Observational data: associations, not effects.
Safety
| Outcome | Paroxysmal AF | Persistent AF |
|---|---|---|
| Primary safety end point: serious procedure- and device-related adverse events | 0.7% (95% CI 0.1–4.6) | 0.7% (95% CI 0.1–4.6) |
Original publication
Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. Published 6 March 2023. doi:10.1161/circulationaha.123.063988
Summarised from the published abstract; every number is checked against it