Arrhythmias & electrophysiology
High-Voltage Focal Pulsed-field Ablation (PFA) Catheter for “Instant” Point-By-Point Ablation: The First-In-Human FIELD-PULSE Trial to Treat AF
Authors' conclusion
Subsecond, high-voltage focal PFA enabled efficient point-by-point ablation and individualized lesion sets without the need for prolonged catheter stability. These first-in-human data support continued clinical development of an instantaneous focal PFA workflow.
Study context
- Population
- Patients with atrial fibrillation undergoing pulmonary vein isolation (PVI) with a focal high-voltage PFA catheterpatients who underwent PFA
- Participants
- 35 patients
- Comparison
- Waveform A vs waveform B vs waveform C
- Waveform An = 15
- Waveform Bn = 5
- Waveform Cn = 15
- Outcome
- Acute PVI
Methodological detailsthree sequential waveform/electrode-configuration cohorts
- Three sequential waveform/electrode-configuration cohorts
Main finding
As reported in the abstract
PF lesions per patient
39
IQR: 35–45
Median elapsed ablation time
13 (IQR: 10-15) minutes
Further findings
- Per-vein PVI durability at remapping · ∼90 days — waveform C
- 94.2%
- Per-vein PVI durability at remapping: Remapping in 32 patients
Per-vein PVI durability at remapping · ∼90 days
- Progressive improvement in PVI durability with waveform evolution
Freedom from atrial arrhythmia · Twelve-month
- Twelve-month freedom from atrial arrhythmia
- 73.9% (95% CI: 60.6%-90.2%)
Safety
Brain magnetic resonance imaging lesions
- Diffusion-weighted imaging (DWI)+/fluid-attenuated inversion recovery (FLAIR)+ lesions
- no
- DWI+/FLAIR- lesions
- 2 (14%)
- Brain magnetic resonance imaging (n = 14)
Primary safety events, haptoglobin depletion, acute kidney injury
- There were no primary safety events, haptoglobin depletion, or acute kidney injury
Original publication
High-Voltage Focal PFA Catheter for “Instant” Point-By-Point Ablation: The First-In-Human FIELD-PULSE Trial to Treat AF. JACC Clin Electrophysiol. Published 9 September 2026. doi:10.
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