Arrhythmias & electrophysiology
Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study
Authors' conclusion
The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.
Study context
- Population
- Predominantly Asian/Chinese patients with drug-refractory paroxysmal AF28 operators
- Participants
- 143 patients12 hospitals
- Outcome
- Freedom from any atrial arrhythmias lasting ≥30 s
- Follow-up
- 12 months
Methodological detailsmulticentre (12 hospitals)
- Multicentre (12 hospitals)
Main finding
As reported in the abstract
12-month freedom from any atrial arrhythmias lasting ≥30 s
Primary endpoint observed in 124 of 143 patients
86.7%
Further findings
Acute PVI success
- All pulmonary vein (PVs) successfully isolated (565/565)
- 100%
Procedural times
- Total procedure time
- 123.5 ± 38.8 min
- Catheter dwell time
- 63.0 ± 30.7 min
- Total pulsed field ablation (PFA) application time
- 169.7 ± 34.6 s
- Total fluoroscopy time
- 27.3 ± 10.1 min
Safety
Small pericardial effusion 1-month post-procedure, not requiring intervention
- Pericardial effusion in one patient
- 0.7%
Original publication
Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study. Europace. Published 24 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →