Heart Rhythm 2025: New Advancements in Emerging Pulsed Field Ablation Tech

The Heart Rhythm Society (HRS) has announced new study findings that demonstrate the safety and efficacy of emerging pulsed field ablation (PFA) systems.

PFA has revolutionized atrial fibrillation (AF) treatment over the past decade. In the last year, the U.S. Food and Drug Administrsation (FDA) has approved PFA technology from three manufacturers based on promising study 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 Demonstrate Safety and Effectiveness of Globe Pulsed Field System for Paroxysmal AF

Kardium Inc.’s pivotal PULSAR Investigational Device Exemption (IDE) study is an international, multi-center, single-arm FDA clinical trial evaluating the safety and effectiveness of the Globe Pulsed Field System for treating paroxysmal AF. Researchers treated 183 patients (average age 65, 40% women) in 12 medical centers in the United States, Europe, and Canada. The procedure was efficient, with mapping taking 9.1 minutes on average, ablation lasting 25.5 minutes, catheter dwell time at 59.9 minutes, and a total procedure time of 95.8 minutes. Ninety-four percent 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, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital in New York, N.Y. “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 Shows Promising Results for FieldForce Ablation System in Treating Scar-Related Ventricular Tachycardia

The Ventricular Catheter Ablation Study (VCAS) is an international, multi-center trial evaluating the safety and performance of the FieldForce Ablation System for treating scar-related ventricular tachycardia (VT), the first and only contact force PFA system designed specifically for VT treatment. Results from patients in two centers with ICDs revealed a quick transpired ablation time of 35 minutes and a fluoroscopy time of 15 minutes. Most importantly, in a patient subset, 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 of 22 patients experienced significant worsening 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,” Dr. Reddy stated. “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 Reports 100% Acute Success in Treating Symptomatic Paroxysmal AF with OMNYPULSE Platform

Omny-IRE is a prospective, multi-center, non-randomized clinical trial currently ongoing in Europe and Canada evaluating the safety and effectiveness of the OMNYPULSE Platform for mapping and treating symptomatic paroxysmal AF during standard ablation procedures. Among 136 patients treated, median pulmonary vein isolation with the OMNYPULSE Platform took 105.5 minutes, with five minutes of total fluoroscopy time. The results showed 100% acute PVI with durable isolation in 84.5% of pulmonary veins at three-month remapping and a 3% 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, M.D., 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.”

The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients and is the primary information resource on heart rhythm disorders. Its mission is to improve patient care by promoting research, education, and optimal healthcare policies and standards. Incorporated in 1979 and based in Washington, D.C., it has a membership of more than 9,000 heart rhythm professionals from 94 countries.

The Heart Rhythm Society’s annual Heart Rhythm meeting convenes 9,500 clinicians, scientists, researchers, and innovators in cardiac pacing and electrophysiology. More than 2,000 international experts serve as faculty for the more than 200 educational sessions, forums, symposia, and ceremonies, while over 110 exhibitors showcase products and services.

Reference
ⁱ HRS and ACC Joint Comment on Coverage for Pulsed Field Ablation