The Omnypulse catheter, a novel contact force-sensing pulsed field ablation (PFA) system, has demonstrated safety and promising efficacy in first-in-human trials for patients with paroxysmal atrial fibrillation (AF), according to data presented at Heart Rhythm 2025.
The prospective, single-arm, multicenter Omny-IRE study evaluated 136 patients across 13 centers in Europe and Canada, achieving 100% acute procedural success in pulmonary vein isolation (PVI), a critical procedure for treating AF.
"The Omnypulse platform is an investigational system that combines pulsed field ablation therapy and mapping via the CARTO 3 system to treat symptomatic paroxysmal atrial fibrillation," explained Dr. Mattias Duytschaever, electrophysiologist at AZ Sint-Jan Brugge Hospital in Belgium and study investigator.
Innovative Catheter Design and Technology
The Omnypulse catheter (Biosense Webster) features several technological innovations designed to improve ablation outcomes. It incorporates a 12 mm large-focal tip with contact force-sensing capabilities and a Trueref reference electrode to reduce far-field unipolar signal interference. The system's Trupulse generator delivers bipolar, biphasic pulse applications through the catheter's 12 electrodes.
A key advancement is the pulsed field index, which quantifies energy delivery by combining real-time contact force feedback with the number of pulsed field applications. In the optimized workflow used for 108 patients, physicians targeted a pulsed field index of 550 on the anterior wall and 400-450 on the posterior wall.
"Following pulsed field index guidance plays a key role in promoting procedural consistency by quantifying energy delivery, contact force and lesion parameters," Dr. Duytschaever noted. "This enables consistent dosing, and helps predict lesion depth based on validated preclinical models to drive lesion durability."
Promising Clinical Outcomes
The study population had a mean age of 60 years (69% male), with an average CHA2DS2-VASc score of 1.6, mean left ventricular ejection fraction of 59%, and mean left atrium diameter of 39.6 mm.
Procedural metrics were favorable, with an average procedure time of 106 minutes and a mean of 61 pulsed field ablations per procedure. More importantly, the durability of pulmonary vein isolation was demonstrated in a subgroup of 29 participants who underwent invasive remapping at a mean follow-up of 82 days, with 84.5% of veins remaining isolated.
The safety profile was encouraging, with only four patients experiencing adverse events. Three cases involved procedure-related vascular access-site complications or bleeding, while one patient developed pericarditis. Importantly, none of these events were adjudicated as related to the ablation catheter itself.
Comparison with Other PFA Technologies
The Omnypulse results come amid growing interest in pulsed field ablation technologies for AF treatment. At the same conference, data was presented on the Globe catheter (Kardium), a spherical, all-in-one PFA system that showed similarly promising results in the PULSAR IDE trial.
The Globe device demonstrated 78% freedom from treatment failure at 12 months in 183 patients across 12 international sites. Notably, pulmonary vein isolation was durable in 95% of assessed veins during repeat procedures, which were required in only 6% of participants.
Dr. Vivek Reddy from Mount Sinai Hospital, who presented the Globe data, highlighted the technology's safety profile: "This was the first time the majority of these operators had used this technology, with the device-related primary adverse events rate of 0% and a procedure-related safety events rate of 0.6%."
Advancing AF Treatment
Both technologies represent significant advancements in the treatment of paroxysmal AF, a condition characterized by irregular heartbeats that start and stop suddenly, typically lasting less than seven days.
Traditional radiofrequency ablation has been the standard approach for AF treatment, but pulsed field ablation offers potential advantages in tissue selectivity and safety. PFA uses high-voltage electrical fields to create pores in cell membranes (electroporation), leading to cell death while potentially reducing damage to surrounding tissues.
"While direct head-to-head comparisons are not yet available, Omnypulse demonstrates comparable or superior acute success with high pulmonary vein durability paired with promising early safety," Dr. Duytschaever said.
Future Directions
The Omnypulse team plans to present 12-month data from the European and Canadian cohort in the future, while a U.S. study is currently ongoing. Similarly, the Globe catheter, which has not yet received commercial approval in the U.S. or Europe, will be evaluated in patients with persistent AF in the next phase of research.
These developments suggest that the landscape of AF treatment is evolving rapidly, with new technologies potentially offering improved outcomes and safety profiles for patients suffering from this common cardiac arrhythmia.
