Pulsed field ablation using a large-tip focal contact force–sensing catheter with 3-dimensional mapping integration: 12-Month outcomes from the OMNY-AF pilot phase

Q: What is the clinical evidence from this study?

Population: Paroxysmal atrial fibrillation (n=30). Intervention: Pulsed field ablation (OMNYPULSE Catheter). Primary outcome: 12-month freedom from primary effectiveness failure (atrial tachyarrhythmia or other failure modes) (95% CI 79.3-100.0).

Dinesh C Sharma; Moussa Mansour; Aneesh Tolat; Mark Metzl; C F Liu; Charles A. Athill; Luigi Di Biase; Stavros Mountantonakis; Vivek Y. Reddy; Walid Saliba; Andrea Natale; David Newton

doi:10.1016/j.hroo.2026.02.031

March 1, 2026Heart Rhythm O2Open Access

Pulsed field ablation using a large-tip focal contact force–sensing catheter with 3-dimensional mapping integration: 12-Month outcomes from the OMNY-AF pilot phase

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Key result

Focal pulsed field ablation achieves ~90% 12-month arrhythmia freedom with zero primary adverse events.

95% CI 79.3-100.0
n=30

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Why the study?

Pulsed field ablation using a large-tip focal contact force-sensing catheter with 3D mapping integration has demonstrated favorable 3-month safety and efficacy, but 12-month safety and effectiveness data in the US are lacking.

Key Points

To evaluate the 12-month safety, procedural effectiveness, and occurrence of postablation cerebral emboli using a large-tip focal contact force–sensing pulsed field ablation catheter in patients with paroxysmal atrial fibrillation.
Prospective, single-arm, multicenter pilot trial (NCT06455098) enrolling 30 patients across 8 US centers with paroxysmal atrial fibrillation undergoing pulmonary vein isolation.
Ablation was conducted using a large-tip focal pulsed field ablation catheter with contact-force sensing and 3-dimensional mapping integration, with recommended contact force of 20–50 g and pulsed field index parameters.
Pre- and postablation cerebral MRI (diffusion-weighted imaging and fluid-attenuated inversion recovery) and standardized neurological examinations were assessed, with rhythm follow-up through 12 months via 12-lead ECG, 24-hour Holter monitoring, and transtelephonic monitoring.
Primary effectiveness success reached 90% freedom from documented atrial tachyarrhythmias (≥30 seconds) or secondary failure modes at 12 months, with 100% acute procedure success.
The primary safety endpoint yielded zero primary adverse events, zero MRI-detected cerebral emboli or lesions, and zero new or worsening neurological deficits.
Median procedure time was 106.0 minutes (interquartile range 81.0–139.0 minutes), and median fluoroscopy time was 0 minutes (interquartile range 0–1.6 minutes), with 56.7% of procedures performed without fluoroscopy.

Structured PICO

P

Population

30 patients with paroxysmal atrial fibrillation underwent pulsed field ablation and were followed for 12 months in a single-arm pilot study.

I

Intervention

Pulsed field ablation (PFA) using a large-tip focal PFA platform with contact force (CF)-sensing and pulsed field (PF) index capabilities (OMNYPULSE Catheter and TRUPULSE Generator).

O

Outcome

Co-primary endpoints: Primary safety endpoint was the incidence of primary adverse events (PAEs). Primary effectiveness endpoint was 12-month freedom from documented (symptomatic/asymptomatic) atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) episodes ≥30 seconds during the effectiveness evaluation period (days 91–365) and additional failure modes.composite

Limitations

Small sample size of 30 patients
Single-arm design lacking a control group
Pilot phase results that require confirmation in a larger pivotal trial

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Implication

The OMNY-AF pilot phase demonstrated that a large-tip focal pulsed field ablation catheter with contact force sensing is safe and effective for paroxysmal AF, notably with no silent cerebral lesions detected on MRI.

Abstract

Pulsed field ablation (PFA) has emerged as an effective technology for treating atrial fibrillation (AF).1,2 Although periprocedural stroke or transient ischemic attack risk is low, brain magnetic resonance imaging (MRI) studies report 7%-42% rates of silent cerebral events or lesions after catheter ablation.3 The large-tip focal PFA Platform with contact-force (CF)-sensing and pulsed field (PF) index capabilities (OMNYPULSE Catheter and TRUPULSE Generator; Biosense Webster, Inc., part of Johnson & Johnson MedTech, Irvine, CA) has demonstrated favorable 3-month safety and acute efficacy in the first-in-human European study.

Discussion

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Cite This Study

Sharma et al. (2026) studied Paroxysmal atrial fibrillation (n=30). Pulsed field ablation (OMNYPULSE Catheter) was evaluated on 12-month freedom from primary effectiveness failure (atrial tachyarrhythmia or other failure modes) (95% CI 79.3-100.0). Pulsed field ablation using the OMNYPULSE catheter demonstrated 0 primary adverse events and achieved 90.0% freedom from primary effectiveness failure at 12 months in patients with paroxysmal atrial fibrillation.

synapsesocial.com/papers/6a025cbcedf6f4813859492e https://doi.org/10.1016/j.hroo.2026.02.031

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Pulsed field ablation using a large-tip focal contact force–sensing catheter with 3-dimensional mapping integration: 12-Month outcomes from the OMNY-AF pilot phase

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Pulsed field ablation using a large-tip focal contact force–sensing catheter with 3-dimensional mapping integration: 12-Month outcomes from the OMNY-AF pilot phase

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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