Arrhythmias & electrophysiology
One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation
Authors' conclusion
The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical effectiveness, even in continuously monitored patients.
Study context
- Population
- Patients with paroxysmal AF undergoing pulmonary vein isolation (PVI) with a large-lattice single-shot pulsed-field ablation (PFA) catheter (Sphere-360)
- Participants
- 100 patients3 centres
- Exposure
- PULSE1 vs PULSE2 vs PULSE3
- PULSE1n = 30
- PULSE2n = 20
- PULSE3n = 50
- Outcome
- Acute PVI and freedom from atrial arrhythmias after 90-day blanking
- Follow-up
- 12 months
Methodological detailsmulticentre, 3 centres
- Multicentre
- 3 centres
Main finding
As reported in the abstract
Freedom from AA recurrence · 1 year
PULSE3
88.0%
95% CI 75.2%–94.4%
- Overall freedom from atrial arrhythmias (AA) recurrence
- 82.0% (95% CI 73.0%-88.3%)
- All targeted PVs acutely isolated
- 395
Observational data: associations, not effects.
Further findings
- PVI durability at remapping (PULSE3, n = 40)
- 98% · per-vein · per-patient 93%
- Insertable loop recorder (ILR) sub-cohort (n = 15 PULSE3 patients)
- 20% · 3
Procedural times
- Procedure time, minutes
- 57.9 ± 20.6
- Left atrial dwell time, minutes
- 22.2 ± 11.8
- Fluoroscopy time, minutes
- 6.8 ± 5.7
- Transpired PVI time, minutes
- 11.5 ± 6.0
- Lesions/PV
- 4.0 ± 1.3
Safety
Primary safety events (serious device-related events within 7 days post-PFA)
- No primary safety events
Original publication
One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation. Heart Rhythm. Published 26 April 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →