April 27, 2025 – The Heart Rhythm Society (HRS) has announced the findings of new studies demonstrating the safety and efficacy of emerging pulsed field ablation (PFA) systems during Heart Rhythm 2025 in San Diego, California.
PFA has revolutionized the treatment of atrial fibrillation (AF) over the past decade. In the last year, the FDA has approved PFA technology from three manufacturers based on promising clinical trial data. Both HRS and the American College of Cardiology (ACC) recognize the extensive body of published evidence, which includes both clinical trials and real-world registry data.i These studies suggest that PFA is an effective alternative to traditional thermal-based catheter ablation for AF, demonstrating comparable efficacy and a potentially improved safety profile. As PFA becomes more widely adopted globally, it will be critical to further investigate and monitor the short- and long-term effects of this treatment through larger, longer-term studies.
Researchers presented the following findings as late-breaking clinical trials during Heart Rhythm 2025.
One-Year Outcomes of PULSAR Trial
Kardium Inc.’s PULSAR Investigational Device Exemption (IDE) study is an international, multi-center, single-arm FDA clinical trial designed to evaluate the safety and effectiveness of the Globe Pulsed Field System for the treatment of paroxysmal AF. Researchers treated 183 patients (average age 65, 40% women) in 12 medical centers across the US, Europe and Canada. The procedure was efficient, with mapping taking an average of 9.1 minutes, ablation lasting 25.5 minutes, catheter dwell time at 59.9 minutes, and a total procedure time of 95.8 minutes. 94% of pulmonary veins were successfully ablated with the first application, with no device-related primary safety events. After 12 months, more than 78% of patients remained free from paroxysmal AF.
“These results set a new bar for treating patients with paroxysmal atrial fibrillation,” said Vivek Reddy, MD, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York. “Building on previous research, we know that this single-shot spherical array PFA catheter can safely create durable lesions. These long-lasting pulmonary vein isolation outcomes significantly enhance the success of paroxysmal atrial fibrillation ablation, exceeding what was previously thought possible.”
First-in-Human VCAS Trial
The Ventricular Catheter Ablation Study (VCAS) is an international, multi-center trial designed to evaluate the safety and performance of the FieldForce Ablation System for the treatment of scar-related ventricular tachycardia (VT) – the contact force PFA system is designed specifically to treat VT. Results from patients in two centers with ICDs revealed a quick transpired ablation time of only 35 minutes and a fluoroscopy time of 15 minutes. Most importantly, in a subset of patients, the investigators demonstrated that ablation from within the heart created full-thickness ablation lesions, also translating to an excellent rate (78%) of freedom from VT. In this very sick population, two out of 22 patients experienced a significant worsening of heart failure.
“Although we've made significant progress in understanding scar-related VT, there remains a lack of data on the effectiveness of PFA as a treatment option, especially considering the thick, fibrotic scar tissue,” said Dr. Reddy. “The results from the VCAS study highlight that PFA shows great promise as a treatment for scar-related VT, and the potential for this technology to transform care for complex ventricular arrhythmias is profound, likely surpassing the current standard of care.”
First-in-Human Omny-IRE Trial
Omny-IRE is a prospective, multi-center, non-randomized clinical trial currently ongoing in Europe and Canada to evaluate the safety and effectiveness of the OMNYPULSE Platform for the mapping and treatment of symptomatic paroxysmal AF during standard ablation procedures. Among 136 patients treated, median pulmonary vein isolation with the OMNYPULSE™ Platform took 105.5 minutes, with only five minutes of total fluoroscopy time. The results showed 100% acute PVI with durable isolation in 84.5% of pulmonary veins at 3-month remapping and a 3.0% primary adverse event rate, with only 0.7% being potentially catheter related.
“The Omny-IRE trial demonstrates the significant potential of the OMNYPULSE Platform and its integration with the CARTO™ 3 System in treating symptomatic paroxysmal AF safety and effectively,” said Mattias Duytschaever, MD, St. Jan Hospital, Brugge-Oostende, Belgium. “As we continue to explore the rapidly evolving clinical impact of PFA, the results from this trial are a significant step forward.”
Click here to read the iHRS and ACC Joint Comment on Coverage for Pulsed Field Ablation.
April 29, 2025 
