Biosense Webster has announced the completion of enrollment for the Omny-IRE clinical trial, a significant step in evaluating the company's Omnypulse platform for the treatment of symptomatic paroxysmal atrial fibrillation (AF). The prospective, multicenter, non-randomized trial enrolled 188 patients across Europe and Canada.
The Omny-IRE trial is designed to assess the safety and effectiveness of the Omnypulse platform during standard ablation procedures. Jennifer Currin, vice president, scientific affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech, stated that the trial aims to advance the understanding of pulsed field ablation (PFA) and provide electrophysiologists with versatile tools for optimal patient care.
Omnypulse Platform Details
The Omnypulse platform comprises the Omnypulse catheter and Trupulse generator, integrating PFA therapy with the Carto 3 3D electroanatomical mapping system. The investigational Omnypulse catheter features a large-tip, 12mm focal catheter with contact force sensing and a Trueref reference electrode to minimize far-field unipolar signal interference. The Trupulse Generator delivers a bipolar, biphasic pulse to the catheter's twelve electrodes. The Carto 3 system software provides a pulsed field (PF) index value for each ablation, calculated using real-time contact force feedback and the number of pulsed field applications.
Investigator Insights
Mattias Duytschaever (AZ Sint-Jan Hospital, Brugge, Belgium), who performed cases as part of the Omny-IRE trial, noted that the integrated Omnypulse platform allowed for seamless mapping and pulsed field energy delivery. He emphasized the value of contact force data from the Omnypulse catheter in ensuring tissue contact before ablation and enabling PF index calculation during energy delivery.
Johan Vijgen (Jessa Hospital, Hasselt, Belgium) also highlighted the importance of clinical trials like Omny-IRE in advancing the field of PFA. He found the PF Index and contact-force feedback valuable for making patient-tailored treatment decisions during procedures using the Omnypulse platform.
