Interim first-in-human clinical safety and efficacy results for Medtronic’s Sphere-360 investigational single-shot mapping and ablation catheter using pulsed field (PF) energy, for treatment of patients with paroxysmal atrial fibrillation (AF) were presented as a late-breaking clinical trial at the European Heart Rhythm Association (EHRA) 2024 congress (7–9 April, Berlin, Germany).
The Sphere-360 study, a prospective, single arm, multicentre trial performed in three European centres with a total of 85 patients, demonstrated 81.8% freedom from atrial arrhythmias after one year of follow up, and 100% freedom in the sub-group treated with the optimised and most recent pulse configuration. The treatment time, or first to last PF application, was 10 minutes on average.
A sub-study of patients treated with the optimised pulse underwent remapping procedures; 96% of those patients demonstrated sustained lesion durability, and among all the pulmonary veins (PV) treated in this group, 99% remained isolated after 75 days of the index procedure.
The study also showed the catheter to have a favourable safety profile, with zero incidences of primary safety adverse events including oesophageal events, pulmonary vein stenosis, phrenic nerve injury or cardiac tamponade.
“Electrophysiologists are seeking innovative catheter options to address the varied cardiac anatomies encountered in patients, and as the population with atrial fibrillation continues to rise, catheter versatility will become more important than ever to achieve the most favourable outcomes,” said Vivek Reddy (Icahn School of Medicine at Mount Sinai, New York, USA), primary investigator of the Sphere-360 trial. “These results are very encouraging as they show the Sphere-360 catheter has the potential to be an important part of next generation AF care.”
Worldwide, the single-shot Sphere-360 catheter is investigational and not approved for sale or distribution. The Affera mapping and ablation system, which includes the focal Sphere-9 catheter and Affera mapping system, received CE mark approval in March 2023.
