Biosense Webster has announced the enrolment completion of the Omny-IRE clinical trial.
Omny-IRE is a prospective, multicentre, non-randomised clinical trial that enrolled 188 patients in Europe and Canada to evaluate the safety and effectiveness of the Biosense Webster Omnypulse platform for the mapping and treatment of symptomatic paroxysmal atrial fibrillation (AF) during standard ablation procedures.
“With the Omny-IRE trial now fully enrolled, we are continuing to make important progress in advancing our collective knowledge and understanding of pulsed field ablation (PFA),” said Jennifer Currin, vice president, scientific affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “Our hope is that the integrated Omnypulse platform will be an exciting new tool in a versatile portfolio of PFA solutions that Biosense Webster is advancing to provide electrophysiologists with a suite of tools they need to deliver optimal procedures for their patients.”
The Omnypulse platform, consisting of the Omnypulse catheter and Trupulse generator, combines PFA therapy and mapping via the Carto 3 3D electroanatomical mapping system.
The investigational Omnypulse catheter is the first large-tip, 12mm focal catheter with contact force sensing and a Trueref reference electrode to reduce the impact of far-field unipolar signals.
The investigational Trupulse Generator provides a bipolar, biphasic pulse application to the catheter’s twelve electrodes. With the Carto 3 system software used in the study, clinicians were able to obtain a pulsed field (PF) index value for each ablation, which is a calculation using the real-time contact force feedback combined with the number of pulsed field applications.
“In the cases I performed as part of the Omny-IRE trial, the integrated Omnypulse platform enabled me to both map and deliver pulsed field energy in a seamless way,” said Mattias Duytschaever (AZ Sint-Jan Hospital, Brugge, Belgium). “The contact force data from the Omnypulse catheter gave me confidence regarding tissue contact before the ablation, and then enabled the PF index calculation during energy delivery.”
“It is exciting to play a part in advancing the field of PFA through clinical trials such as Omny-IRE,” said Johan Vijgen (Jessa Hospital, Hasselt, Belgium). “In my experience with the Omnypulse platform as part of the study, I found the PF Index and contact-force feedback very valuable in making patient-tailored treatment decisions during the procedures.”
