September 1, 2026JACC. Clinical electrophysiology
High-Voltage Focal PFA Catheter for “Instant” Point-By-Point Ablation
Key result
Focal pulsed-field ablation achieves ~74% 1-year freedom from atrial arrhythmia with 100% acute PVI.
- 95% CI 60.6%-90.2%
- n=35
JACC. Clinical electrophysiology published a graphical abstract
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Why the study?
Existing focal PFA technologies require energy delivery over multiple cardiac and respiratory cycles, limiting procedural efficiency and catheter stability.
Does a subsecond, high-voltage focal PFA catheter enable efficient and durable point-by-point pulmonary vein isolation safely in patients with atrial fibrillation?
Structured PICO
Does a subsecond, high-voltage focal PFA catheter enable efficient and durable point-by-point pulmonary vein isolation safely in patients with atrial fibrillation?
P
Population
35 patients with atrial fibrillation undergoing point-by-point pulmonary vein isolation with a novel high-voltage focal pulsed-field ablation catheter.
I
Intervention
8.5-F force-sensing focal pulsed-field ablation (PFA) catheter delivering a single QRS-synchronized, high-voltage (≥10 kV; <200 ms) pulsed field application for point-by-point ablation (tested in three sequential waveform cohorts: A [n=15], B [n=5], and C [n=15])
O
Outcome
Acute pulmonary vein isolation (PVI), PVI durability at approximately 90 days, safety, and 12-month freedom from atrial arrhythmiacomposite
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The Field PULSE results reinforce our approach of deliberately architecting focal PFA to address the fundamental limitations of existing methods, then validating its application through data. By delivering each ablation point in a fraction of a second, we reduce dependence on prolonged catheter stability, limit the impact of cardiac motion, and establish a platform approach for treating complex arrhythmias.”
“We designed FieldForce to solve some of the hardest problems in focal cardiac ablation, beginning in the ventricle. Field PULSE demonstrates that the same high-voltage focal PFA architecture can support an instantaneous ablation workflow in the atrium. This growing body of evidence reinforces the range of the platform: depth and focal control in the ventricle, speed and precision in the atrium, and the versatility to address very different cardiac substrates through a familiar point-by-point approach.”
DADr. Arash AryaHead of Invasive Electrophysiology
“The important innovation is not simply another PFA catheter—it is the possibility of combining the speed normally associated with single-shot PFA with the anatomical flexibility of focal point-by-point ablation. A <200-ms lesion could substantially reduce the importance of prolonged catheter stability and make complex non-PV lesion sets much faster. The 94% chronic PVI durability is particularly encouraging.”
Implication
A novel high-voltage focal PFA catheter demonstrates feasibility, safety, and high lesion durability for instantaneous point-by-point pulmonary vein isolation in atrial fibrillation.
Abstract
BACKGROUND 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. OBJECTIVES The authors sought to evaluate a focal PFA catheter delivering a novel subsecond pulsed-field waveform designed for "instantaneous" point-by-point ablation. METHODS 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. RESULTS 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%). CONCLUSIONS 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. CLINICALTRIALS 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).
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Cite This Study
Reddy et al. (2026) studied Atrial Fibrillation (n=35). High-Voltage Focal PFA Catheter (FieldForce Ablation System) was evaluated on 12-month freedom from atrial arrhythmia (95% CI 60.6%-90.2%). High-voltage focal pulsed-field ablation achieved acute pulmonary vein isolation in 100% of patients and a 12-month freedom from atrial arrhythmia of 73.9% (95% CI: 60.6%-90.2%).