High-Voltage Focal PFA Catheter for "Instant" Point-By-Point Ablation: The First-In-Human FIELD-PULSE Trial to Treat...

Single-shot pulsed-field ablation (PFA) catheters are widely used for pulmonary vein isolation (PVI) because of their efficiency, but they are less suited for flexible lesion sets. Existing focal PFA technologies permit individualized ablation but require energy delivery over multiple cardiac and respiratory cycles, making sustained catheter stability important and potentially reducing procedural efficiency.

The authors sought to evaluate a focal PFA catheter delivering a novel subsecond pulsed-field waveform designed for "instantaneous" point-by-point ablation.

An 8.5-F force-sensing PFA catheter delivers a single QRS-synchronized, high-voltage (≥10 kV; <200 ms) pulsed field application. Three sequential waveform/electrode-configuration cohorts were evaluated. PVI was guided by conventional electroanatomic mapping, with impedance-based catheter localization. A subset underwent post-PFA brain magnetic resonance imaging. Invasive remapping at ∼90 days assessed lesion durability.

Thirty-five patients underwent PFA with waveform A (n = 15), B (n = 5), or C (n = 15). Acute PVI was achieved in all patients, requiring 39 (IQR: 35-45) PF lesions per patient, with a median elapsed ablation time of 13 (IQR: 10-15) minutes. Remapping in 32 patients demonstrated progressive improvement in PVI durability with waveform evolution: Waveform C achieved 94.2% per-vein PVI durability. Brain magnetic resonance imaging (n = 14) demonstrated no diffusion-weighted imaging (DWI)+/fluid-attenuated inversion recovery (FLAIR)+ lesions and 2 DWI+/FLAIR- lesions (14%). There were no primary safety events, haptoglobin depletion, or acute kidney injury. Twelve-month freedom from atrial arrhythmia was 73.9% (95% CI: 60.6%-90.2%).

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.

gov: (The FIELD-PULSE Study; A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce Ablation System in Patients with Atrial Fibrillation; NCT06452589).