Kardium has announced late-breaking, one-year clinical trial results with its innovative pulsed field ablation (PFA) device—the Globe PF system.
Pivotal findings from the PULSAR investigational device exemption (IDE) study were announced at the 2025 Heart Rhythm Society (HRS) annual meeting (24–27 April, San Diego, USA), highlighting data on the safety and efficacy of the Globe PF system, which is currently under premarket approval (PMA) review with the US Food and Drug Administration (FDA).
According to Kardium, key results included a 0% rate of device-related primary safety events, 78% 12-month primary effectiveness, 100% acute procedural success, a 25-minute average time to isolate all pulmonary veins, and an average of 1.2 PFA applications per vein.
“These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF system,” said Vivek Reddy (Mount Sinai Fuster Heart Hospital, New York City, USA), the study’s co-principal investigator. “Given the excellent durability achieved by the Globe PF system, the efficacy result is likely approaching the limit of what we can achieve with PV [pulmonary vein] isolation alone.”
Kardium claims that, with just 1.2 applications per vein, the Globe PF system is “the true single-shot PFA solution” with integrated mapping and ablation built into a single catheter.
“We are very pleased with the study’s safety results,” commented co-principal investigator Atul Verma (McGill University Health Centre, Montreal, Canada). “The Globe PF system has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualised, patient‑centred treatment decisions.”
The PULSAR IDE study is a global, prospective, multicentre, single-arm study intended to demonstrate the safety and long-term efficacy of the Globe PF system. It enrolled 183 patients across 12 centres in the USA, Europe and Canada with symptomatic paroxysmal atrial fibrillation (AF). The data presented at HRS 2025 were preliminary and the full data will be included in a publication, as per a recent press release from Kardium.
“These are truly outstanding results from the PULSAR IDE study,” said Kevin Chaplin, chief executive officer (CEO) of Kardium. “The Globe PF system achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.”
