PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF: Omny-IRE 3-Month Results

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• The Omny-IRE study evaluated the OMNYPULSE catheter, a novel large-tip, multielectrode, contact force-sensing pulsed field ablation device integrated with electroanatomic mapping.
• This technology aims to improve the treatment of paroxysmal atrial fibrillation (PAF).

Purpose of the Study:

• To assess the 3-month safety and effectiveness of the OMNYPULSE platform for treating symptomatic paroxysmal atrial fibrillation.
• To evaluate the durability of pulmonary vein isolation (PVI) achieved with the novel catheter system.

Main Methods:

• Pulmonary vein isolation (PVI) was performed using the OMNYPULSE Platform.
• Primary effectiveness was defined as adenosine/isoproterenol-proof entrance block.
• Primary safety was assessed by the occurrence of primary adverse events, with prespecified subsets undergoing brain imaging, esophageal endoscopy, and cardiac imaging.

Main Results:

• 100% acute effectiveness (136/136 patients) was achieved.
• The primary adverse event rate was 3.0% (4/135 patients), including vascular access complications and pericarditis.
• Pulmonary vein isolation (PVI) durability was 62.1% at 3 months, improving to 71.4% with an optimized workflow.

Conclusions:

• The force-sensing, large-focal pulsed field ablation catheter with integrated 3D electroanatomic mapping demonstrated 100% acute success for paroxysmal atrial fibrillation treatment.
• The platform exhibited a promising safety profile.
• Prespecified remapping indicated good PVI durability, suggesting potential for effective long-term treatment.